MDedge Pediatrics

The Food and Drug Administration has cleared Beta Bionics’s iLet ACE Pump and the iLet Dosing Decision Software for people ages 6 years and older with type 1 diabetes.
 

Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.

Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.

In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).

The FDA had granted the iLet a breakthrough device designation in December 2019.

Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.

Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”

That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”

On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”

The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has cleared Beta Bionics’s iLet ACE Pump and the iLet Dosing Decision Software for people ages 6 years and older with type 1 diabetes.
 

Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.

Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.

In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).

The FDA had granted the iLet a breakthrough device designation in December 2019.

Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.

Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”

That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”

On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”

The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has cleared Beta Bionics’s iLet ACE Pump and the iLet Dosing Decision Software for people ages 6 years and older with type 1 diabetes.
 

Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.

Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.

In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).

The FDA had granted the iLet a breakthrough device designation in December 2019.

Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.

Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”

That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”

On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”

The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.

A version of this article first appeared on Medscape.com.

AURORA, COLO. – Artificial Intelligence has arrived at medical offices, whether or not clinicians feel ready for it.

AI might result in more accurate, efficient, and cost-effective care. But it’s possible it could cause harm. That’s according to Benjamin Collins, MD, at Vanderbilt University Medical Center, Nashville, Tenn., who spoke on the subject at the annual meeting of the Society of General Internal Medicine.

Understanding the nuances of AI is even more important because of the quick development of the algorithms.

“When I submitted this workshop, there was no ChatGPT,” said Dr. Collins, referring to Chat Generative Pre-trained Transformer, a recently released natural language processing model. “A lot has already changed.”
 

Biased data

Biased data are perhaps the biggest pitfall of AI algorithms, Dr. Collins said. If garbage data go in, garbage predictions come out.

If the dataset that trains the algorithm underrepresents a particular gender or ethnic group, for example, the algorithm may not respond accurately to prompts. When an AI tool compounds existing inequalities related to socioeconomic status, ethnicity, or sexual orientation, the algorithm is biased, according to Harvard researchers.

“People often assume that artificial intelligence is free of bias due to the use of scientific processes and its development,” he said. “But whatever flaws exist in data collection and old data can lead to poor representation or underrepresentation in the data used to train the AI tool.”

Racial minorities are underrepresented in studies; therefore, data input into an AI tool might skew results for these patients.

The Framingham Heart Study, for example, which began in 1948, examined heart disease in mainly White participants. The findings from the study resulted in the creation of a sex-specific algorithm that was used to estimate the 10-year cardiovascular risk of a patient. While the cardiovascular risk score was accurate for White persons, it was less accurate for Black patients.

A study published in Science in 2019 revealed bias in an algorithm that used health care costs as a proxy for health needs. Because less money was spent on Black patients who had the same level of need as their White counterparts, the output inaccurately showed that Black patients were healthier and thus did not require extra care.

Developers can also be a source of bias, inasmuch as AI often reflects preexisting human biases, Dr. Collins said.

“Algorithmic bias presents a clear risk of harm that clinicians must play against the benefits of using AI,” Dr. Collins said. “That risk of harm is often disproportionately distributed to marginalized populations.”

As clinicians use AI algorithms to diagnose and detect disease, predict outcomes, and guide treatment, trouble comes when those algorithms perform well for some patients and poorly for others. This gap can exacerbate existing disparities in health care outcomes.

Dr. Collins advised clinicians to push to find out what data were used to train AI algorithms to determine how bias could have influenced the model and whether the developers risk-adjusted for bias. If the training data are not available, clinicians should ask their employers and AI developers to know more about the system.

Clinicians may face the so-called black box phenomenon, which occurs when developers cannot or will not explain what data went into an AI model, Dr. Collins said.

According to Stanford (Calif.) University, AI must be trained on large datasets of images that have been annotated by human experts. Those datasets can cost millions of dollars to create, meaning corporations often fund them and do not always share the data publicly.

Some groups, such as Stanford’s Center for Artificial Intelligence in Medicine and Imaging, are working to acquire annotated datasets so researchers who train AI models can know where the data came from.

Paul Haidet, MD, MPH, an internist at Penn State College of Medicine, Hershey, sees the technology as a tool that requires careful handling.

“It takes a while to learn how to use a stethoscope, and AI is like that,” Dr. Haidet said. “The thing about AI, though, is that it can be just dropped into a system and no one knows how it works.”

Dr. Haidet said he likes knowing how the sausage is made, something AI developers are often reticent to make known.

“If you’re just putting blind faith in a tool, that’s scary,” Dr. Haidet said.
 

Transparency and ‘explainability’

The ability to explain what goes into tools is essential to maintaining trust in the health care system, Dr. Collins said.

“Part of knowing how much trust to place in the system is the transparency of those systems and the ability to audit how well the algorithm is performing,” Dr. Collins said. “The system should also regularly report to users the level of certainty with which it is providing an output rather than providing a simple binary output.”

Dr. Collins recommends that providers develop an understanding of the limits of AI regulations as well, which might including learning how the system was approved and how it is monitored.

“The FDA has oversight over some applications of AI and health care for software as a medical device, but there’s currently no dedicated process to evaluate the systems for the presence of bias,” Dr. Collins said. “The gaps in regulation leave the door open for the use of AI in clinical care that contain significant biases.”

Dr. Haidet likened AI tools to the Global Positioning System: A good GPS system will let users see alternate routes, opt out of toll roads or highways, and will highlight why routes have changed. But users need to understand how to read the map so they can tell when something seems amiss.

Dr. Collins and Dr. Haidet report no relevant financial relationships

A version of this article first appeared on Medscape.com.

AURORA, COLO. – Artificial Intelligence has arrived at medical offices, whether or not clinicians feel ready for it.

AI might result in more accurate, efficient, and cost-effective care. But it’s possible it could cause harm. That’s according to Benjamin Collins, MD, at Vanderbilt University Medical Center, Nashville, Tenn., who spoke on the subject at the annual meeting of the Society of General Internal Medicine.

Understanding the nuances of AI is even more important because of the quick development of the algorithms.

“When I submitted this workshop, there was no ChatGPT,” said Dr. Collins, referring to Chat Generative Pre-trained Transformer, a recently released natural language processing model. “A lot has already changed.”
 

Biased data

Biased data are perhaps the biggest pitfall of AI algorithms, Dr. Collins said. If garbage data go in, garbage predictions come out.

If the dataset that trains the algorithm underrepresents a particular gender or ethnic group, for example, the algorithm may not respond accurately to prompts. When an AI tool compounds existing inequalities related to socioeconomic status, ethnicity, or sexual orientation, the algorithm is biased, according to Harvard researchers.

“People often assume that artificial intelligence is free of bias due to the use of scientific processes and its development,” he said. “But whatever flaws exist in data collection and old data can lead to poor representation or underrepresentation in the data used to train the AI tool.”

Racial minorities are underrepresented in studies; therefore, data input into an AI tool might skew results for these patients.

The Framingham Heart Study, for example, which began in 1948, examined heart disease in mainly White participants. The findings from the study resulted in the creation of a sex-specific algorithm that was used to estimate the 10-year cardiovascular risk of a patient. While the cardiovascular risk score was accurate for White persons, it was less accurate for Black patients.

A study published in Science in 2019 revealed bias in an algorithm that used health care costs as a proxy for health needs. Because less money was spent on Black patients who had the same level of need as their White counterparts, the output inaccurately showed that Black patients were healthier and thus did not require extra care.

Developers can also be a source of bias, inasmuch as AI often reflects preexisting human biases, Dr. Collins said.

“Algorithmic bias presents a clear risk of harm that clinicians must play against the benefits of using AI,” Dr. Collins said. “That risk of harm is often disproportionately distributed to marginalized populations.”

As clinicians use AI algorithms to diagnose and detect disease, predict outcomes, and guide treatment, trouble comes when those algorithms perform well for some patients and poorly for others. This gap can exacerbate existing disparities in health care outcomes.

Dr. Collins advised clinicians to push to find out what data were used to train AI algorithms to determine how bias could have influenced the model and whether the developers risk-adjusted for bias. If the training data are not available, clinicians should ask their employers and AI developers to know more about the system.

Clinicians may face the so-called black box phenomenon, which occurs when developers cannot or will not explain what data went into an AI model, Dr. Collins said.

According to Stanford (Calif.) University, AI must be trained on large datasets of images that have been annotated by human experts. Those datasets can cost millions of dollars to create, meaning corporations often fund them and do not always share the data publicly.

Some groups, such as Stanford’s Center for Artificial Intelligence in Medicine and Imaging, are working to acquire annotated datasets so researchers who train AI models can know where the data came from.

Paul Haidet, MD, MPH, an internist at Penn State College of Medicine, Hershey, sees the technology as a tool that requires careful handling.

“It takes a while to learn how to use a stethoscope, and AI is like that,” Dr. Haidet said. “The thing about AI, though, is that it can be just dropped into a system and no one knows how it works.”

Dr. Haidet said he likes knowing how the sausage is made, something AI developers are often reticent to make known.

“If you’re just putting blind faith in a tool, that’s scary,” Dr. Haidet said.
 

Transparency and ‘explainability’

The ability to explain what goes into tools is essential to maintaining trust in the health care system, Dr. Collins said.

“Part of knowing how much trust to place in the system is the transparency of those systems and the ability to audit how well the algorithm is performing,” Dr. Collins said. “The system should also regularly report to users the level of certainty with which it is providing an output rather than providing a simple binary output.”

Dr. Collins recommends that providers develop an understanding of the limits of AI regulations as well, which might including learning how the system was approved and how it is monitored.

“The FDA has oversight over some applications of AI and health care for software as a medical device, but there’s currently no dedicated process to evaluate the systems for the presence of bias,” Dr. Collins said. “The gaps in regulation leave the door open for the use of AI in clinical care that contain significant biases.”

Dr. Haidet likened AI tools to the Global Positioning System: A good GPS system will let users see alternate routes, opt out of toll roads or highways, and will highlight why routes have changed. But users need to understand how to read the map so they can tell when something seems amiss.

Dr. Collins and Dr. Haidet report no relevant financial relationships

A version of this article first appeared on Medscape.com.

AURORA, COLO. – Artificial Intelligence has arrived at medical offices, whether or not clinicians feel ready for it.

AI might result in more accurate, efficient, and cost-effective care. But it’s possible it could cause harm. That’s according to Benjamin Collins, MD, at Vanderbilt University Medical Center, Nashville, Tenn., who spoke on the subject at the annual meeting of the Society of General Internal Medicine.

Understanding the nuances of AI is even more important because of the quick development of the algorithms.

“When I submitted this workshop, there was no ChatGPT,” said Dr. Collins, referring to Chat Generative Pre-trained Transformer, a recently released natural language processing model. “A lot has already changed.”
 

Biased data

Biased data are perhaps the biggest pitfall of AI algorithms, Dr. Collins said. If garbage data go in, garbage predictions come out.

If the dataset that trains the algorithm underrepresents a particular gender or ethnic group, for example, the algorithm may not respond accurately to prompts. When an AI tool compounds existing inequalities related to socioeconomic status, ethnicity, or sexual orientation, the algorithm is biased, according to Harvard researchers.

“People often assume that artificial intelligence is free of bias due to the use of scientific processes and its development,” he said. “But whatever flaws exist in data collection and old data can lead to poor representation or underrepresentation in the data used to train the AI tool.”

Racial minorities are underrepresented in studies; therefore, data input into an AI tool might skew results for these patients.

The Framingham Heart Study, for example, which began in 1948, examined heart disease in mainly White participants. The findings from the study resulted in the creation of a sex-specific algorithm that was used to estimate the 10-year cardiovascular risk of a patient. While the cardiovascular risk score was accurate for White persons, it was less accurate for Black patients.

A study published in Science in 2019 revealed bias in an algorithm that used health care costs as a proxy for health needs. Because less money was spent on Black patients who had the same level of need as their White counterparts, the output inaccurately showed that Black patients were healthier and thus did not require extra care.

Developers can also be a source of bias, inasmuch as AI often reflects preexisting human biases, Dr. Collins said.

“Algorithmic bias presents a clear risk of harm that clinicians must play against the benefits of using AI,” Dr. Collins said. “That risk of harm is often disproportionately distributed to marginalized populations.”

As clinicians use AI algorithms to diagnose and detect disease, predict outcomes, and guide treatment, trouble comes when those algorithms perform well for some patients and poorly for others. This gap can exacerbate existing disparities in health care outcomes.

Dr. Collins advised clinicians to push to find out what data were used to train AI algorithms to determine how bias could have influenced the model and whether the developers risk-adjusted for bias. If the training data are not available, clinicians should ask their employers and AI developers to know more about the system.

Clinicians may face the so-called black box phenomenon, which occurs when developers cannot or will not explain what data went into an AI model, Dr. Collins said.

According to Stanford (Calif.) University, AI must be trained on large datasets of images that have been annotated by human experts. Those datasets can cost millions of dollars to create, meaning corporations often fund them and do not always share the data publicly.

Some groups, such as Stanford’s Center for Artificial Intelligence in Medicine and Imaging, are working to acquire annotated datasets so researchers who train AI models can know where the data came from.

Paul Haidet, MD, MPH, an internist at Penn State College of Medicine, Hershey, sees the technology as a tool that requires careful handling.

“It takes a while to learn how to use a stethoscope, and AI is like that,” Dr. Haidet said. “The thing about AI, though, is that it can be just dropped into a system and no one knows how it works.”

Dr. Haidet said he likes knowing how the sausage is made, something AI developers are often reticent to make known.

“If you’re just putting blind faith in a tool, that’s scary,” Dr. Haidet said.
 

Transparency and ‘explainability’

The ability to explain what goes into tools is essential to maintaining trust in the health care system, Dr. Collins said.

“Part of knowing how much trust to place in the system is the transparency of those systems and the ability to audit how well the algorithm is performing,” Dr. Collins said. “The system should also regularly report to users the level of certainty with which it is providing an output rather than providing a simple binary output.”

Dr. Collins recommends that providers develop an understanding of the limits of AI regulations as well, which might including learning how the system was approved and how it is monitored.

“The FDA has oversight over some applications of AI and health care for software as a medical device, but there’s currently no dedicated process to evaluate the systems for the presence of bias,” Dr. Collins said. “The gaps in regulation leave the door open for the use of AI in clinical care that contain significant biases.”

Dr. Haidet likened AI tools to the Global Positioning System: A good GPS system will let users see alternate routes, opt out of toll roads or highways, and will highlight why routes have changed. But users need to understand how to read the map so they can tell when something seems amiss.

Dr. Collins and Dr. Haidet report no relevant financial relationships

A version of this article first appeared on Medscape.com.

DUBLIN – Nearly half (45%) of adolescents assigned to semaglutide (Wegovy), a once-weekly glucagon-like peptide-1 (GLP-1) agonist, managed to lose enough weight to drop below the clinical threshold for obesity, according to a secondary analysis of the STEP TEENS (Semaglutide Treatment Effect in People With Obesity) trial.
 

By comparison, only 12.1% of adolescents with obesity taking placebo in the trial dropped below the obesity threshold.

The study also found that 74% of participants shifted down by at least one body mass index (BMI) category after receiving the GLP-1 agonist, compared with 19% of those taking placebo.

Semaglutide shifts BMI category

In this new secondary analysis of STEP TEENS, the authors examined the effect of subcutaneous semaglutide 2.4 mg on moving adolescents from one BMI category to another, including dropping below the obesity threshold into the overweight or normal weight categories.

The study also looked at the effect of semaglutide on glucose metabolism and cardiovascular risk factors, as well as safety and tolerability. However, this particular analysis only examined adolescents with obesity (only one person had overweight, and so they were excluded), who were divided into three further subclasses: obesity class I (BMI ≥ 95th to < 20% above the 95th percentile); obesity class II (BMI ≥ 20% to < 40% above 95th percentile); and obesity class III (BMI ≥ 40% above the 95th percentile).

After a 12-week run-in period of lifestyle intervention only, a total of 200 adolescents (12-18 years) with obesity (in the top 5% of BMI) were randomized (2:1) to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks, after a 16-week titration period. All participants continued to receive counseling about healthy nutrition and were set a goal of 60 minutes per day of moderate- to high-intensity physical activity.

Dr. Kelly and colleagues determined levels of improvement in BMI category and attainment of normal weight, or overweight, BMI category by week 68.

At baseline, the percentage of participants in obesity class I, II, or III, in those taking placebo was 39.7%, 41.4%, and 19.0%, or taking semaglutide was 31.4%, 31.4%, and 37.3%, respectively.

“After 68 weeks, not a lot happened [in placebo participants]; however, 12.1% of placebo participants did drop below the obesity threshold into overweight or normal-weight categories,” reported Dr. Kelly.

Referring to participants taking semaglutide, he added that “a total of 45% of patients on semaglutide dropped below the clinical BMI cut point for obesity, such that 19.5% dropped into the overweight category and 25.4% reduced their BMI into the normal-weight category.”

Turning to obesity class, Dr. Kelly reported that of those initially with obesity class III taking placebo, 91% remained in that class and 9.1% dropped to obesity class II at week 68. For those adolescents with obesity class III taking semaglutide, 36.4% dropped to obesity class II, 18.2% dropped to obesity class I, 11% dropped below the obesity threshold, and 34.1% remained in obesity class III, he added.

For obesity class II specifically, 71% of placebo participants stayed in that category, while 12% moved up a category. “On semaglutide, over 50% (51.2%) reduced their BMI below the obesity cut point,” noted Dr. Kelly.

In obesity class I, 26% of patients taking placebo reduced their BMI below the obesity cut point. “On semaglutide, nearly 80% reduced their BMI below the obesity threshold, with 57% dropping their BMI into the normal category,” he said.

“When we looked at baseline factors that might predict the response to semaglutide or placebo, we did not find any factors that were ... significant due to small sample sizes,” he said. However, he pointed out that “females tended to respond better to semaglutide, likewise younger adolescents, and middle body weights tended to respond better to the drug, and there was a similar pattern with obesity classes.”

Commenting on the study, Jesse Bittman, MD, University of British Columbia, Vancouver, said: “Good to see more data on different populations that some semaglutide is used in and the variability in response to it. The focus on BMI was interesting because in obesity medicine we spend a lot of time telling our patients not to focus on BMIs and ‘normals’ because there are more important tools, and we see that when these become the focus of research outcomes they can become problematic.”

Asked whether rapid weight loss in adolescents might be problematic in some respects, Dr. Bittman pointed out that “one concern with these medications is whether people are going to have loss of muscle mass or malnutrition, or whether they develop eating disorders and other disturbed eating behaviors.”

Dr. Kelly has reported engaging in unpaid consulting and educational activities for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus, and receiving donated drug/placebo from Novo Nordisk and Vivus for National Institutes of Health–funded clinical trials. Dr. O’Malley has declared having received grants in the past 3 years from the Health Research Board, Department of Health, Ireland, European Association for the Study of Obesity (via a Novo Nordisk educational grant), Healthy Ireland fund, and the Royal College of Surgeons in Ireland Strategic Academic Recruitment (StAR) Programme. Dr. Bittman has reported receiving funding from Novo Nordisk, Bayer, and Bausch Health.

A version of this article first appeared on Medscape.com.

DUBLIN – Nearly half (45%) of adolescents assigned to semaglutide (Wegovy), a once-weekly glucagon-like peptide-1 (GLP-1) agonist, managed to lose enough weight to drop below the clinical threshold for obesity, according to a secondary analysis of the STEP TEENS (Semaglutide Treatment Effect in People With Obesity) trial.
 

By comparison, only 12.1% of adolescents with obesity taking placebo in the trial dropped below the obesity threshold.

The study also found that 74% of participants shifted down by at least one body mass index (BMI) category after receiving the GLP-1 agonist, compared with 19% of those taking placebo.

Semaglutide shifts BMI category

In this new secondary analysis of STEP TEENS, the authors examined the effect of subcutaneous semaglutide 2.4 mg on moving adolescents from one BMI category to another, including dropping below the obesity threshold into the overweight or normal weight categories.

The study also looked at the effect of semaglutide on glucose metabolism and cardiovascular risk factors, as well as safety and tolerability. However, this particular analysis only examined adolescents with obesity (only one person had overweight, and so they were excluded), who were divided into three further subclasses: obesity class I (BMI ≥ 95th to < 20% above the 95th percentile); obesity class II (BMI ≥ 20% to < 40% above 95th percentile); and obesity class III (BMI ≥ 40% above the 95th percentile).

After a 12-week run-in period of lifestyle intervention only, a total of 200 adolescents (12-18 years) with obesity (in the top 5% of BMI) were randomized (2:1) to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks, after a 16-week titration period. All participants continued to receive counseling about healthy nutrition and were set a goal of 60 minutes per day of moderate- to high-intensity physical activity.

Dr. Kelly and colleagues determined levels of improvement in BMI category and attainment of normal weight, or overweight, BMI category by week 68.

At baseline, the percentage of participants in obesity class I, II, or III, in those taking placebo was 39.7%, 41.4%, and 19.0%, or taking semaglutide was 31.4%, 31.4%, and 37.3%, respectively.

“After 68 weeks, not a lot happened [in placebo participants]; however, 12.1% of placebo participants did drop below the obesity threshold into overweight or normal-weight categories,” reported Dr. Kelly.

Referring to participants taking semaglutide, he added that “a total of 45% of patients on semaglutide dropped below the clinical BMI cut point for obesity, such that 19.5% dropped into the overweight category and 25.4% reduced their BMI into the normal-weight category.”

Turning to obesity class, Dr. Kelly reported that of those initially with obesity class III taking placebo, 91% remained in that class and 9.1% dropped to obesity class II at week 68. For those adolescents with obesity class III taking semaglutide, 36.4% dropped to obesity class II, 18.2% dropped to obesity class I, 11% dropped below the obesity threshold, and 34.1% remained in obesity class III, he added.

For obesity class II specifically, 71% of placebo participants stayed in that category, while 12% moved up a category. “On semaglutide, over 50% (51.2%) reduced their BMI below the obesity cut point,” noted Dr. Kelly.

In obesity class I, 26% of patients taking placebo reduced their BMI below the obesity cut point. “On semaglutide, nearly 80% reduced their BMI below the obesity threshold, with 57% dropping their BMI into the normal category,” he said.

“When we looked at baseline factors that might predict the response to semaglutide or placebo, we did not find any factors that were ... significant due to small sample sizes,” he said. However, he pointed out that “females tended to respond better to semaglutide, likewise younger adolescents, and middle body weights tended to respond better to the drug, and there was a similar pattern with obesity classes.”

Commenting on the study, Jesse Bittman, MD, University of British Columbia, Vancouver, said: “Good to see more data on different populations that some semaglutide is used in and the variability in response to it. The focus on BMI was interesting because in obesity medicine we spend a lot of time telling our patients not to focus on BMIs and ‘normals’ because there are more important tools, and we see that when these become the focus of research outcomes they can become problematic.”

Asked whether rapid weight loss in adolescents might be problematic in some respects, Dr. Bittman pointed out that “one concern with these medications is whether people are going to have loss of muscle mass or malnutrition, or whether they develop eating disorders and other disturbed eating behaviors.”

Dr. Kelly has reported engaging in unpaid consulting and educational activities for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus, and receiving donated drug/placebo from Novo Nordisk and Vivus for National Institutes of Health–funded clinical trials. Dr. O’Malley has declared having received grants in the past 3 years from the Health Research Board, Department of Health, Ireland, European Association for the Study of Obesity (via a Novo Nordisk educational grant), Healthy Ireland fund, and the Royal College of Surgeons in Ireland Strategic Academic Recruitment (StAR) Programme. Dr. Bittman has reported receiving funding from Novo Nordisk, Bayer, and Bausch Health.

A version of this article first appeared on Medscape.com.

DUBLIN – Nearly half (45%) of adolescents assigned to semaglutide (Wegovy), a once-weekly glucagon-like peptide-1 (GLP-1) agonist, managed to lose enough weight to drop below the clinical threshold for obesity, according to a secondary analysis of the STEP TEENS (Semaglutide Treatment Effect in People With Obesity) trial.
 

By comparison, only 12.1% of adolescents with obesity taking placebo in the trial dropped below the obesity threshold.

The study also found that 74% of participants shifted down by at least one body mass index (BMI) category after receiving the GLP-1 agonist, compared with 19% of those taking placebo.

Semaglutide shifts BMI category

In this new secondary analysis of STEP TEENS, the authors examined the effect of subcutaneous semaglutide 2.4 mg on moving adolescents from one BMI category to another, including dropping below the obesity threshold into the overweight or normal weight categories.

The study also looked at the effect of semaglutide on glucose metabolism and cardiovascular risk factors, as well as safety and tolerability. However, this particular analysis only examined adolescents with obesity (only one person had overweight, and so they were excluded), who were divided into three further subclasses: obesity class I (BMI ≥ 95th to < 20% above the 95th percentile); obesity class II (BMI ≥ 20% to < 40% above 95th percentile); and obesity class III (BMI ≥ 40% above the 95th percentile).

After a 12-week run-in period of lifestyle intervention only, a total of 200 adolescents (12-18 years) with obesity (in the top 5% of BMI) were randomized (2:1) to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks, after a 16-week titration period. All participants continued to receive counseling about healthy nutrition and were set a goal of 60 minutes per day of moderate- to high-intensity physical activity.

Dr. Kelly and colleagues determined levels of improvement in BMI category and attainment of normal weight, or overweight, BMI category by week 68.

At baseline, the percentage of participants in obesity class I, II, or III, in those taking placebo was 39.7%, 41.4%, and 19.0%, or taking semaglutide was 31.4%, 31.4%, and 37.3%, respectively.

“After 68 weeks, not a lot happened [in placebo participants]; however, 12.1% of placebo participants did drop below the obesity threshold into overweight or normal-weight categories,” reported Dr. Kelly.

Referring to participants taking semaglutide, he added that “a total of 45% of patients on semaglutide dropped below the clinical BMI cut point for obesity, such that 19.5% dropped into the overweight category and 25.4% reduced their BMI into the normal-weight category.”

Turning to obesity class, Dr. Kelly reported that of those initially with obesity class III taking placebo, 91% remained in that class and 9.1% dropped to obesity class II at week 68. For those adolescents with obesity class III taking semaglutide, 36.4% dropped to obesity class II, 18.2% dropped to obesity class I, 11% dropped below the obesity threshold, and 34.1% remained in obesity class III, he added.

For obesity class II specifically, 71% of placebo participants stayed in that category, while 12% moved up a category. “On semaglutide, over 50% (51.2%) reduced their BMI below the obesity cut point,” noted Dr. Kelly.

In obesity class I, 26% of patients taking placebo reduced their BMI below the obesity cut point. “On semaglutide, nearly 80% reduced their BMI below the obesity threshold, with 57% dropping their BMI into the normal category,” he said.

“When we looked at baseline factors that might predict the response to semaglutide or placebo, we did not find any factors that were ... significant due to small sample sizes,” he said. However, he pointed out that “females tended to respond better to semaglutide, likewise younger adolescents, and middle body weights tended to respond better to the drug, and there was a similar pattern with obesity classes.”

Commenting on the study, Jesse Bittman, MD, University of British Columbia, Vancouver, said: “Good to see more data on different populations that some semaglutide is used in and the variability in response to it. The focus on BMI was interesting because in obesity medicine we spend a lot of time telling our patients not to focus on BMIs and ‘normals’ because there are more important tools, and we see that when these become the focus of research outcomes they can become problematic.”

Asked whether rapid weight loss in adolescents might be problematic in some respects, Dr. Bittman pointed out that “one concern with these medications is whether people are going to have loss of muscle mass or malnutrition, or whether they develop eating disorders and other disturbed eating behaviors.”

Dr. Kelly has reported engaging in unpaid consulting and educational activities for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus, and receiving donated drug/placebo from Novo Nordisk and Vivus for National Institutes of Health–funded clinical trials. Dr. O’Malley has declared having received grants in the past 3 years from the Health Research Board, Department of Health, Ireland, European Association for the Study of Obesity (via a Novo Nordisk educational grant), Healthy Ireland fund, and the Royal College of Surgeons in Ireland Strategic Academic Recruitment (StAR) Programme. Dr. Bittman has reported receiving funding from Novo Nordisk, Bayer, and Bausch Health.

A version of this article first appeared on Medscape.com.

Douglas Lunsford’s son Samuel has struggled with obesity all his life.

Just before turning 14, Samuel, now 25, took part in a program at Ohio-based Nationwide Children’s Hospital’s Center for Healthy Weight and Nutrition. The program consisted of twice-weekly meetings with a nutritionist, including lessons in food portion size, what food does within the body, what foods can be used to supplement other foods, and similar topics, as well as physical exercise. 

Although the program was designed for youngsters with weight problems, Mr. Lunsford also took part. 

“They would exercise us and work us out,” he said.

Father and son did the program together for 2 years. Since then, Mr. Lunsford has advocated for youngsters with obesity. 

“Samuel’s struggle spurred us into action,” he said. 

Eventually, Mr. Lunsford helped create the American Academy of Pediatrics’ recently released Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity. 
 

Helping create change

According to Sandra Hassink, MD, coauthor of the guideline and vice chair of the Clinical Practice Guideline Subcommittee on Obesity, the goal was to “help patients make changes in lifestyle, behaviors, or environment in a sustainable way and also to involve families in decision-making at every step of the way.”

The guideline recommends comprehensive obesity treatment that may include nutritional support, exercise, behavioral therapy, medication, and metabolic and bariatric surgery.

Ideally, a child would receive intense behavioral and lifestyle treatment, although this approach isn’t always available and might be challenging to deliver. The most effective treatments include at least 26 hours of face-to-face, family-based treatments, consisting of many different components and lasting 3-12 months.

The guideline suggests that doctors offer adolescents 12 and older medication to assist in weight loss, along with health, behavior, and lifestyle treatment, and that teens who have severe obesity should consider metabolic and bariatric surgery as they continue intense health behavior and lifestyle treatment. 

“We’re living at a time where we’ve watched obesity affect our children and adult population for 4 decades and, along with the risk of obesity, we’ve watched a rise in obesity; we’re seeing increases in illness that go along with obesity, such as type 2 diabetes, lipid diseases like high cholesterol, and nonalcoholic fatty liver disease,” Dr. Hassink said.

She explained that, as people gain weight, the cells in adipose (fatty) tissues start to malfunction and produce inflammatory chemicals that cause these illnesses. 

“So having extra adipose tissue is a risk,” she said. “As pediatricians, we measure body mass index [BMI] – which is calculated based on height and weight – as a way of seeing whether the child could be at risk for developing these dysfunctioning cells. If so, we screen them for prediabetes, lipid disease, or liver disease and other obesity-related comorbidities.”

In addition, “we’re concerned about the mental health of children with obesity because of the weight bias in our culture,” said Dr. Hassink. “A child gets stigmatized, and this takes the form of bullying and teasing, and leads to low self-esteem, depression, and anxiety. So we know we have a host of physical problems we need to look out for, as well as the emotional and psychological effects of how our culture views things.”
 

Are parents ready for the new approach?

A new report from Harmony Healthcare IT, a data management firm that works with health data, looked at how parents regard their children’s obesity. The company surveyed more than 1,000 parents and found that one-tenth of respondents had children who were overweight or obese and over a quarter (26%) worried about their child’s weight.

Nearly 40% of parents would consider weight loss medication for their child if the child became obese at age 12, and about 16% would consider weight loss surgery. But most parents would not consider this surgery until their child was an average age of 15 rather than the AAP’s recommended age of 13.

Mr. Lunsford said that his son considered surgery and medication but was “never comfortable” with these approaches. 

This isn’t unusual, Dr. Hassink said. “Not every parent will think the same way, and their view will be based on their experience and what’s going on with their child.”

The guideline wasn’t designed to encourage every child to try medication or have surgery, she said. 

“But parents now know that there are potentially helpful choices here that we didn’t have years ago, and those can be discussed with the child’s pediatrician.”
 

Challenges to keeping healthy

It’s tough to stay healthy and not develop obesity in our modern environment, Dr. Hassink said. 

“There’s a lot of processed food, a lot of sugar in our foods, a lot of sedentary behavior, and a decrease in physical activity. In many communities, it’s hard for people to get healthy foods.”

Mr. Lunsford said that when his son was in his late teens and would go out with friends, they typically went to fast-food restaurants. 

“Sam would say ‘yes’ to these foods, although he knew they weren’t good for him, because he wanted to be like everyone else,” he said.

But parents now know that there are potentially helpful choices here that we didn’t have years ago, and those can be discussed with the child’s pediatrician, he said.

Harmony Health IT’s survey found that many parents say it is a struggle to get kids to eat healthy foods and get enough sleep. Although almost all respondents (83%) said they try to prepare healthy, home-cooked meals, 39% eat fast food at least once a week, mostly because parents are too tired to cook. 

Dr. Hassink said the COVID-19 pandemic also played a role.

“We knew that COVID would be hard for kids with obesity, and there might be weight gain because of the extra sedentary time and fewer sporting activities, and there was a high cost of food to families who are already economically strapped,” she said. 

In general, family support is essential, Dr. Hassink said. “Obesity treatment requires that the family be involved. The family is living in the same nutritional and activity environment as their child. Everyone has to be on board.”
 

Talking to kids about food and weight

The survey found that many parents struggle to talk about food and weight with their children. The AAP guideline notes that involving a health care professional can help. 

“If a parent or caregiver is concerned about a child’s weight, he or she can take the child to their pediatrician,” Dr. Hassink said. “The first thing the pediatrician will do is ask about the child’s overall health, review the family history – because obesity tends to run in families – and see if other conditions, like diabetes, also run in the family.” 

The pediatrician will do a physical examination that includes BMI and, if it’s high, other tests looking at blood sugar, lipids, and liver function may be performed. 

Ideally, the child will be prescribed intense lifestyle and behavioral treatment that will take the child’s and family’s nutrition into account, as well as physical activity and the amount of sleep the child is getting, which is sometimes tied to weight gain. If the child has disordered eating, such as binge eating disorder, they can be evaluated and treated for that.

Each child is seen as an individual with a particular set of needs. “One size doesn’t fit all,” Dr. Hassink said. 
 

Providing emotional support for children with obesity 

Pediatricians can assess the child’s mental, emotional, and social well-being. “Children who are bullied or teased may need help working through that. Children experiencing depression may need treatment,” Dr. Hassink said.

Mr. Lunsford said Samuel was fortunate in that he rarely got taunted. 

“Part of the reason is that, although weight was an issue, he never allowed his weight to define him,” he said. “He was always an extroverted kind of kid, athletic, very outgoing and friendly, and being overweight was never part of his identity.” 

Mr. Lunsford encourages parents whose children are teased or bullied to create a “no-judgment” zone at home. 

“Let your kids know that their parents love them for who they are,” he said. “Emphasize that weight is a ‘number’ and health is a ‘lifestyle.’ Try to highlight the good things in their lives and encourage them to be as active as they can in the things that interest them.”

A version of this article originally appeared on WebMD.com.

Douglas Lunsford’s son Samuel has struggled with obesity all his life.

Just before turning 14, Samuel, now 25, took part in a program at Ohio-based Nationwide Children’s Hospital’s Center for Healthy Weight and Nutrition. The program consisted of twice-weekly meetings with a nutritionist, including lessons in food portion size, what food does within the body, what foods can be used to supplement other foods, and similar topics, as well as physical exercise. 

Although the program was designed for youngsters with weight problems, Mr. Lunsford also took part. 

“They would exercise us and work us out,” he said.

Father and son did the program together for 2 years. Since then, Mr. Lunsford has advocated for youngsters with obesity. 

“Samuel’s struggle spurred us into action,” he said. 

Eventually, Mr. Lunsford helped create the American Academy of Pediatrics’ recently released Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity. 
 

Helping create change

According to Sandra Hassink, MD, coauthor of the guideline and vice chair of the Clinical Practice Guideline Subcommittee on Obesity, the goal was to “help patients make changes in lifestyle, behaviors, or environment in a sustainable way and also to involve families in decision-making at every step of the way.”

The guideline recommends comprehensive obesity treatment that may include nutritional support, exercise, behavioral therapy, medication, and metabolic and bariatric surgery.

Ideally, a child would receive intense behavioral and lifestyle treatment, although this approach isn’t always available and might be challenging to deliver. The most effective treatments include at least 26 hours of face-to-face, family-based treatments, consisting of many different components and lasting 3-12 months.

The guideline suggests that doctors offer adolescents 12 and older medication to assist in weight loss, along with health, behavior, and lifestyle treatment, and that teens who have severe obesity should consider metabolic and bariatric surgery as they continue intense health behavior and lifestyle treatment. 

“We’re living at a time where we’ve watched obesity affect our children and adult population for 4 decades and, along with the risk of obesity, we’ve watched a rise in obesity; we’re seeing increases in illness that go along with obesity, such as type 2 diabetes, lipid diseases like high cholesterol, and nonalcoholic fatty liver disease,” Dr. Hassink said.

She explained that, as people gain weight, the cells in adipose (fatty) tissues start to malfunction and produce inflammatory chemicals that cause these illnesses. 

“So having extra adipose tissue is a risk,” she said. “As pediatricians, we measure body mass index [BMI] – which is calculated based on height and weight – as a way of seeing whether the child could be at risk for developing these dysfunctioning cells. If so, we screen them for prediabetes, lipid disease, or liver disease and other obesity-related comorbidities.”

In addition, “we’re concerned about the mental health of children with obesity because of the weight bias in our culture,” said Dr. Hassink. “A child gets stigmatized, and this takes the form of bullying and teasing, and leads to low self-esteem, depression, and anxiety. So we know we have a host of physical problems we need to look out for, as well as the emotional and psychological effects of how our culture views things.”
 

Are parents ready for the new approach?

A new report from Harmony Healthcare IT, a data management firm that works with health data, looked at how parents regard their children’s obesity. The company surveyed more than 1,000 parents and found that one-tenth of respondents had children who were overweight or obese and over a quarter (26%) worried about their child’s weight.

Nearly 40% of parents would consider weight loss medication for their child if the child became obese at age 12, and about 16% would consider weight loss surgery. But most parents would not consider this surgery until their child was an average age of 15 rather than the AAP’s recommended age of 13.

Mr. Lunsford said that his son considered surgery and medication but was “never comfortable” with these approaches. 

This isn’t unusual, Dr. Hassink said. “Not every parent will think the same way, and their view will be based on their experience and what’s going on with their child.”

The guideline wasn’t designed to encourage every child to try medication or have surgery, she said. 

“But parents now know that there are potentially helpful choices here that we didn’t have years ago, and those can be discussed with the child’s pediatrician.”
 

Challenges to keeping healthy

It’s tough to stay healthy and not develop obesity in our modern environment, Dr. Hassink said. 

“There’s a lot of processed food, a lot of sugar in our foods, a lot of sedentary behavior, and a decrease in physical activity. In many communities, it’s hard for people to get healthy foods.”

Mr. Lunsford said that when his son was in his late teens and would go out with friends, they typically went to fast-food restaurants. 

“Sam would say ‘yes’ to these foods, although he knew they weren’t good for him, because he wanted to be like everyone else,” he said.

But parents now know that there are potentially helpful choices here that we didn’t have years ago, and those can be discussed with the child’s pediatrician, he said.

Harmony Health IT’s survey found that many parents say it is a struggle to get kids to eat healthy foods and get enough sleep. Although almost all respondents (83%) said they try to prepare healthy, home-cooked meals, 39% eat fast food at least once a week, mostly because parents are too tired to cook. 

Dr. Hassink said the COVID-19 pandemic also played a role.

“We knew that COVID would be hard for kids with obesity, and there might be weight gain because of the extra sedentary time and fewer sporting activities, and there was a high cost of food to families who are already economically strapped,” she said. 

In general, family support is essential, Dr. Hassink said. “Obesity treatment requires that the family be involved. The family is living in the same nutritional and activity environment as their child. Everyone has to be on board.”
 

Talking to kids about food and weight

The survey found that many parents struggle to talk about food and weight with their children. The AAP guideline notes that involving a health care professional can help. 

“If a parent or caregiver is concerned about a child’s weight, he or she can take the child to their pediatrician,” Dr. Hassink said. “The first thing the pediatrician will do is ask about the child’s overall health, review the family history – because obesity tends to run in families – and see if other conditions, like diabetes, also run in the family.” 

The pediatrician will do a physical examination that includes BMI and, if it’s high, other tests looking at blood sugar, lipids, and liver function may be performed. 

Ideally, the child will be prescribed intense lifestyle and behavioral treatment that will take the child’s and family’s nutrition into account, as well as physical activity and the amount of sleep the child is getting, which is sometimes tied to weight gain. If the child has disordered eating, such as binge eating disorder, they can be evaluated and treated for that.

Each child is seen as an individual with a particular set of needs. “One size doesn’t fit all,” Dr. Hassink said. 
 

Providing emotional support for children with obesity 

Pediatricians can assess the child’s mental, emotional, and social well-being. “Children who are bullied or teased may need help working through that. Children experiencing depression may need treatment,” Dr. Hassink said.

Mr. Lunsford said Samuel was fortunate in that he rarely got taunted. 

“Part of the reason is that, although weight was an issue, he never allowed his weight to define him,” he said. “He was always an extroverted kind of kid, athletic, very outgoing and friendly, and being overweight was never part of his identity.” 

Mr. Lunsford encourages parents whose children are teased or bullied to create a “no-judgment” zone at home. 

“Let your kids know that their parents love them for who they are,” he said. “Emphasize that weight is a ‘number’ and health is a ‘lifestyle.’ Try to highlight the good things in their lives and encourage them to be as active as they can in the things that interest them.”

A version of this article originally appeared on WebMD.com.

Douglas Lunsford’s son Samuel has struggled with obesity all his life.

Just before turning 14, Samuel, now 25, took part in a program at Ohio-based Nationwide Children’s Hospital’s Center for Healthy Weight and Nutrition. The program consisted of twice-weekly meetings with a nutritionist, including lessons in food portion size, what food does within the body, what foods can be used to supplement other foods, and similar topics, as well as physical exercise. 

Although the program was designed for youngsters with weight problems, Mr. Lunsford also took part. 

“They would exercise us and work us out,” he said.

Father and son did the program together for 2 years. Since then, Mr. Lunsford has advocated for youngsters with obesity. 

“Samuel’s struggle spurred us into action,” he said. 

Eventually, Mr. Lunsford helped create the American Academy of Pediatrics’ recently released Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity. 
 

Helping create change

According to Sandra Hassink, MD, coauthor of the guideline and vice chair of the Clinical Practice Guideline Subcommittee on Obesity, the goal was to “help patients make changes in lifestyle, behaviors, or environment in a sustainable way and also to involve families in decision-making at every step of the way.”

The guideline recommends comprehensive obesity treatment that may include nutritional support, exercise, behavioral therapy, medication, and metabolic and bariatric surgery.

Ideally, a child would receive intense behavioral and lifestyle treatment, although this approach isn’t always available and might be challenging to deliver. The most effective treatments include at least 26 hours of face-to-face, family-based treatments, consisting of many different components and lasting 3-12 months.

The guideline suggests that doctors offer adolescents 12 and older medication to assist in weight loss, along with health, behavior, and lifestyle treatment, and that teens who have severe obesity should consider metabolic and bariatric surgery as they continue intense health behavior and lifestyle treatment. 

“We’re living at a time where we’ve watched obesity affect our children and adult population for 4 decades and, along with the risk of obesity, we’ve watched a rise in obesity; we’re seeing increases in illness that go along with obesity, such as type 2 diabetes, lipid diseases like high cholesterol, and nonalcoholic fatty liver disease,” Dr. Hassink said.

She explained that, as people gain weight, the cells in adipose (fatty) tissues start to malfunction and produce inflammatory chemicals that cause these illnesses. 

“So having extra adipose tissue is a risk,” she said. “As pediatricians, we measure body mass index [BMI] – which is calculated based on height and weight – as a way of seeing whether the child could be at risk for developing these dysfunctioning cells. If so, we screen them for prediabetes, lipid disease, or liver disease and other obesity-related comorbidities.”

In addition, “we’re concerned about the mental health of children with obesity because of the weight bias in our culture,” said Dr. Hassink. “A child gets stigmatized, and this takes the form of bullying and teasing, and leads to low self-esteem, depression, and anxiety. So we know we have a host of physical problems we need to look out for, as well as the emotional and psychological effects of how our culture views things.”
 

Are parents ready for the new approach?

A new report from Harmony Healthcare IT, a data management firm that works with health data, looked at how parents regard their children’s obesity. The company surveyed more than 1,000 parents and found that one-tenth of respondents had children who were overweight or obese and over a quarter (26%) worried about their child’s weight.

Nearly 40% of parents would consider weight loss medication for their child if the child became obese at age 12, and about 16% would consider weight loss surgery. But most parents would not consider this surgery until their child was an average age of 15 rather than the AAP’s recommended age of 13.

Mr. Lunsford said that his son considered surgery and medication but was “never comfortable” with these approaches. 

This isn’t unusual, Dr. Hassink said. “Not every parent will think the same way, and their view will be based on their experience and what’s going on with their child.”

The guideline wasn’t designed to encourage every child to try medication or have surgery, she said. 

“But parents now know that there are potentially helpful choices here that we didn’t have years ago, and those can be discussed with the child’s pediatrician.”
 

Challenges to keeping healthy

It’s tough to stay healthy and not develop obesity in our modern environment, Dr. Hassink said. 

“There’s a lot of processed food, a lot of sugar in our foods, a lot of sedentary behavior, and a decrease in physical activity. In many communities, it’s hard for people to get healthy foods.”

Mr. Lunsford said that when his son was in his late teens and would go out with friends, they typically went to fast-food restaurants. 

“Sam would say ‘yes’ to these foods, although he knew they weren’t good for him, because he wanted to be like everyone else,” he said.

But parents now know that there are potentially helpful choices here that we didn’t have years ago, and those can be discussed with the child’s pediatrician, he said.

Harmony Health IT’s survey found that many parents say it is a struggle to get kids to eat healthy foods and get enough sleep. Although almost all respondents (83%) said they try to prepare healthy, home-cooked meals, 39% eat fast food at least once a week, mostly because parents are too tired to cook. 

Dr. Hassink said the COVID-19 pandemic also played a role.

“We knew that COVID would be hard for kids with obesity, and there might be weight gain because of the extra sedentary time and fewer sporting activities, and there was a high cost of food to families who are already economically strapped,” she said. 

In general, family support is essential, Dr. Hassink said. “Obesity treatment requires that the family be involved. The family is living in the same nutritional and activity environment as their child. Everyone has to be on board.”
 

Talking to kids about food and weight

The survey found that many parents struggle to talk about food and weight with their children. The AAP guideline notes that involving a health care professional can help. 

“If a parent or caregiver is concerned about a child’s weight, he or she can take the child to their pediatrician,” Dr. Hassink said. “The first thing the pediatrician will do is ask about the child’s overall health, review the family history – because obesity tends to run in families – and see if other conditions, like diabetes, also run in the family.” 

The pediatrician will do a physical examination that includes BMI and, if it’s high, other tests looking at blood sugar, lipids, and liver function may be performed. 

Ideally, the child will be prescribed intense lifestyle and behavioral treatment that will take the child’s and family’s nutrition into account, as well as physical activity and the amount of sleep the child is getting, which is sometimes tied to weight gain. If the child has disordered eating, such as binge eating disorder, they can be evaluated and treated for that.

Each child is seen as an individual with a particular set of needs. “One size doesn’t fit all,” Dr. Hassink said. 
 

Providing emotional support for children with obesity 

Pediatricians can assess the child’s mental, emotional, and social well-being. “Children who are bullied or teased may need help working through that. Children experiencing depression may need treatment,” Dr. Hassink said.

Mr. Lunsford said Samuel was fortunate in that he rarely got taunted. 

“Part of the reason is that, although weight was an issue, he never allowed his weight to define him,” he said. “He was always an extroverted kind of kid, athletic, very outgoing and friendly, and being overweight was never part of his identity.” 

Mr. Lunsford encourages parents whose children are teased or bullied to create a “no-judgment” zone at home. 

“Let your kids know that their parents love them for who they are,” he said. “Emphasize that weight is a ‘number’ and health is a ‘lifestyle.’ Try to highlight the good things in their lives and encourage them to be as active as they can in the things that interest them.”

A version of this article originally appeared on WebMD.com.

This transcript has been edited for clarity.

Andrew N. Wilner, MD: I’m your host, Dr. Andrew Wilner, reporting virtually from the 2023 American Academy of Neurology meeting in Boston. It’s my pleasure today to speak with Dr. Shae Datta, codirector of the NYU Langone Concussion Center.

She’s also a clinical assistant professor of neurology at NYU School of Medicine. Dr. Datta is chair of the AAN Sports Neurology Section, and she’s leading a panel on concussion at this year’s meeting. She’s going to give us an update. Welcome, Dr. Datta.

Shae Datta, MD: Thank you so much, Andrew. I really love the fact that I’m here speaking to you about all of the new, exciting developments in the field.

Dr. Wilner: Before we get too deep, tell us how you got interested in this topic.

Dr. Datta: I initially thought, when I was in training as a resident, that I wanted to do something like neurocritical care or EEG. It also puzzled me why these seemingly smaller head injuries that didn’t end up in the hospital or ICU were bounced from neurology headache clinic to neuro-ophthalmology headache clinic to neurovestibular headache clinic, and nobody seemed to be able to put together the dots about why they’re having so many different issues — but at the same time, nobody could help them.

At that time, this field was very new. I was on a plane to Paris to a neurocritical care conference as a resident, and I saw the movie Concussion with Will Smith.

It featured one of my current mentors who taught at the fellowship that I graduated from, and it was a fascinating field. I just started looking deeply into it, and I saw that there was a new training fellowship for sports neurology and concussion management, and this is basically why we’re here today.
 

New concussion consensus guidelines coming

Dr. Wilner: I think this field has really exploded. It used to be that you banged your head, you did a CT scan – remember, I trained about 45 years ago – and if there was nothing on the CT scan, you were done. If you had headaches, you took Tylenol until they went away.

Now, we do MRI, and we realized that it’s really a syndrome. I understand that there are going to be some formal guidelines that have been put together. Is that correct?

Dr. Datta: That’s correct. The 6th International Consensus Conference on Concussion in Sport, in Amsterdam, where I attended and presented a poster, was really a meeting of all the best minds – clinicians and researchers in brain injury – to form a consensus on the newest guidelines that are going to direct our treatment going forward.

Dr. Wilner: I’m going to ask you a trick question because the last time I looked it up I did not get a satisfying answer. What is a concussion?

Dr. Datta: That’s a very good question, and everyone always asks. A concussion is an external force that is emitted upon the head or the neck, or the body, in general, that may cause temporary loss of function. It’s a functional problem.

We don’t see much on CT. We can do MRI. We can do SPECT or we can do these very fancy images, sometimes, of high-velocity head injuries and see small microhemorrhages.

Often, we don’t see anything, but still the patient is loopy. They can’t see straight. They are double-visioned. They have vertigo. Why is that happening? On the cellular level, we have an energy deficit in the sodium-potassium-ATPase pump of the neurons themselves.

Dr. Wilner: Suppose you do see diffuse axonal injury; does that take it out of concussion, or can you have a concussion with visible injury?

Dr. Datta: I think you can have overlap in the symptoms. The diffuse axonal injury would put it into a higher grade of head injury as opposed to a mild traumatic brain injury. Definitely, we would need to work together with our trauma doctors to ensure that patients are not on blood thinners or anything until they heal well enough. Obviously, I would pick them up as an outpatient and follow them until we resolve or rehab them as best as possible.

Concussion assessment tools

Dr. Wilner: There are many sports out there where concussions are fairly frequent, like American football and hockey, for example. Are there any statements in the new guidelines?

Dr. Datta: There are no statements for or against a particular sport because that would really make too much of a bold statement about cause and effect. There is a cause and effect in long-term, repetitive exposure, I would say, in terms of someone being able to play or sustain injury.

Right now, at least at the concussion conference I went to and in the upcoming consensus statement, they will not comment on a specific sport. Obviously, we know that the higher-impact sports are a little more dangerous.

Let’s be honest. At the high school, middle school, or even younger level, some kids are not necessarily the most athletic, right? They play because their friends are playing. If they’re repeatedly getting injured, it’s time for an astute clinician, or a coach, and a whole team to assess them to see if maybe this person is just going to continue to get hurt if they’re not taken out of the game and perhaps they should go to a lower-impact sport.

Dr. Wilner: In schools, often there’s a big size and weight difference. There are 14-year-olds who are 6 fett 2 inches and 200 pounds, and there are 14-year-olds who are 5 feet 2 inches and 110 pounds. Obviously, they’re mismatched on the football field.

You mentioned coaches. Is there anything in the guidelines about training coaches?

Dr. Datta: Specifically, there was nothing in the guidelines about that. There’s a tool for coaches at every level to use, which is called the Sports Concussion Assessment Tool, or SCAT, which is going to be updated to the SCAT6. At the NCAA level, they must receive annual training on concussion management and be given an NCAA concussion handout for coaches.

Obviously, there are more rigorous protocols for national-level coaching. As it stands now, it is not mandatory, but they are given tools to assess someone once they’ve gotten a hit to take them out of the game.

Dr. Wilner: I’ve been following the concussion research through the years. They did some neuropsychological testing on athletes who’ve had this many concussions or that many concussions, and they would find deficits here or subtle deficits there, but they had no baseline.

Then, there was a movement to start testing athletes before the season starts so that they could do a repeat test after concussion and see if there is any difference. Is that something we’re recommending?

Dr. Datta: Most of the time, NCAA-level – certainly where I trained – and national-level sports do testing, but it’s not everywhere. Prior guidelines have indicated that preseason testing is not required. That is largely because there has been no standardized neuropsychological testing established.

There are computerized testing options where the validity and reliability are questionable. Also, let’s say it’s a college student; they didn’t sleep all night and then they took this computer test. They would probably do worse than they would if they had received a head hit.

Just to be on the safe side, most places that have collegiate-level sports that are at a high level do preseason testing. If I were to speak personally, aside from the guidelines, I would say that it’s been helpful for me to look at the before and after, in general, overall, to make a decision about my treatment protocol.

Dr. Wilner: Let’s talk about the patient. You have a 20-year-old guy. He’s playing football. There’s a big play. Bonk, he gets hit on the head. He’s on the ground. He’s dazed, staggers a little bit, gets up, and you ask how he is feeling. He says he’s fine and then he wobbles off to the sideline. What do you do with that kid?

Dr. Datta: Obviously, the first thing is to remove him from the play environment to a quiet space. Second, either an athletic trainer or a coach would administer basic screening neurologic tests, such as “where are you, what’s today’s date, what is your name?” and other orientation questions.

They’ll also go through the SCAT – that’ll be SCAT6 starting in July – the SCAT5 symptom questionnaire to see what symptoms they have. Often, they’re using sideline testing software.

There are two things that can be used on a card to test eye movements, to see if they’re slower. They come out of NYU, coincidentally – the Memory Image Completion (MIC) and the Mobile Universal Lexicon Evaluation System (MULES) – and are used to determine whether eye movements are slower. That way, you can tell whether someone is, compared with before they got their head hit, slower than before.

Based on this composite information, usually the teammates and the head people on the team will know if a player looks different.

They need to be taken out, obviously, if there is nausea or vomiting, any neurologic signs and symptoms, or a neck injury that needs to be stabilized. ABCs first, right? If there’s any vomiting or seizures, they should be taken to the ER right away.

The first thing is to take them out, then do a sideline assessment. Third, see if they need to immediately go to the ED versus follow-up outpatient with me within a day or two.

Dr. Wilner: I think it’s the subtle injuries that are the tough ones. Back to our 20-year-old. He says: “Oh, I’m fine. I want to go back in the game.” Everybody can tell he’s not quite right, even though he passed all the tests. What do you do then?

Dr. Datta: You have to make a judgment call for the safety of the player. They always want to go back, right? This is also an issue when they’re competing for college scholarships and things of that nature. Sometimes they’re sandbagging, where they memorize the answers.

Everything’s on the Internet nowadays, right? We have to make a judgment call as members of the healthcare community and the sports community to keep that player safe.

Just keep them out. Don’t bring them back in the game. Keep them out for a reasonable amount of time. There’s a test called the Buffalo Concussion Treadmill Test; Dr. John Leddy from University of Buffalo has developed a way for us to put athletes through a screening protocol.

This can be part of their vestibular and ocular rehabilitation, where if they don’t have symptoms when we bring their heart rate to certain levels, then we can slowly clear them for return to play as long as they’re nonsymptomatic.

Dr. Wilner: I spoke with your colleague, Dr. Riggins, who is also on your panel, and we were talking about when they can go back. She said they can go back when they don’t have any symptoms. No more headache, no more dizziness, no more lightheadedness, no more trouble concentrating or with memory – all those things have gone away.

Sometimes these symptoms are stubborn. If you have, say, 100 patients like our 20-year-old who got bonked on the head, has some headaches, and doesn’t feel quite right, what usually happens? How many are back to play the next day, the next week, or the next month? How many are out for the season? How does that play out?

Dr. Datta: It depends on a couple of different factors. One, have they had previous head injuries? Two, do they have preexisting symptoms or signs, or diagnoses like migraines, which are likely to get worse after a head injury? Anything that’s preexisting, like a mood disorder, anxiety, depression, or trouble sleeping, is going to get worse.

If they were compensating for untreated ADD or borderline personality or bipolar, I’ve seen many people who’ve developed them. These are not the norm, but I’m saying that you have to be very careful.

Getting back to the question, you treat them. Reasonably, if they’re healthy and they don’t have preexisting signs and symptoms, I would say more than half are back in about 2 weeks.. I would say 60%-70%. It all depends. If they have preexisting issues, then it’s going to take much longer.
 

From SCAT to SCOAT

Dr. Wilner: This has been very informative. Before we wrap up, tell us what to expect from these guidelines in July. How are they really going to help?

Dr. Datta: The consensus statement is going to come out with something called a SCOAT, which stands for Sport Concussion Office Assessment Tool. We’ve been using the SCAT, which was meant for more sideline assessment because that’s all we had, and it’s worked perfectly well.

This will be better because we often see them within 24-48 hours, when the symptoms are sometimes a little bit better.

We also will see the sport and concussion group come up with added athlete perspectives, ethics discussion, power-sport athlete considerations, and development of this new SCOAT.

Dr. Wilner: Dr. Datta, this is very exciting. I look forward to reading these guidelines in July. I want to thank you for your hard work. I also look forward to talking to you at next year’s meeting. Thank you very much for giving us this update.

Dr. Datta: No problem. It’s my pleasure.

A version of this article originally appeared on Medscape.com.

This transcript has been edited for clarity.

Andrew N. Wilner, MD: I’m your host, Dr. Andrew Wilner, reporting virtually from the 2023 American Academy of Neurology meeting in Boston. It’s my pleasure today to speak with Dr. Shae Datta, codirector of the NYU Langone Concussion Center.

She’s also a clinical assistant professor of neurology at NYU School of Medicine. Dr. Datta is chair of the AAN Sports Neurology Section, and she’s leading a panel on concussion at this year’s meeting. She’s going to give us an update. Welcome, Dr. Datta.

Shae Datta, MD: Thank you so much, Andrew. I really love the fact that I’m here speaking to you about all of the new, exciting developments in the field.

Dr. Wilner: Before we get too deep, tell us how you got interested in this topic.

Dr. Datta: I initially thought, when I was in training as a resident, that I wanted to do something like neurocritical care or EEG. It also puzzled me why these seemingly smaller head injuries that didn’t end up in the hospital or ICU were bounced from neurology headache clinic to neuro-ophthalmology headache clinic to neurovestibular headache clinic, and nobody seemed to be able to put together the dots about why they’re having so many different issues — but at the same time, nobody could help them.

At that time, this field was very new. I was on a plane to Paris to a neurocritical care conference as a resident, and I saw the movie Concussion with Will Smith.

It featured one of my current mentors who taught at the fellowship that I graduated from, and it was a fascinating field. I just started looking deeply into it, and I saw that there was a new training fellowship for sports neurology and concussion management, and this is basically why we’re here today.
 

New concussion consensus guidelines coming

Dr. Wilner: I think this field has really exploded. It used to be that you banged your head, you did a CT scan – remember, I trained about 45 years ago – and if there was nothing on the CT scan, you were done. If you had headaches, you took Tylenol until they went away.

Now, we do MRI, and we realized that it’s really a syndrome. I understand that there are going to be some formal guidelines that have been put together. Is that correct?

Dr. Datta: That’s correct. The 6th International Consensus Conference on Concussion in Sport, in Amsterdam, where I attended and presented a poster, was really a meeting of all the best minds – clinicians and researchers in brain injury – to form a consensus on the newest guidelines that are going to direct our treatment going forward.

Dr. Wilner: I’m going to ask you a trick question because the last time I looked it up I did not get a satisfying answer. What is a concussion?

Dr. Datta: That’s a very good question, and everyone always asks. A concussion is an external force that is emitted upon the head or the neck, or the body, in general, that may cause temporary loss of function. It’s a functional problem.

We don’t see much on CT. We can do MRI. We can do SPECT or we can do these very fancy images, sometimes, of high-velocity head injuries and see small microhemorrhages.

Often, we don’t see anything, but still the patient is loopy. They can’t see straight. They are double-visioned. They have vertigo. Why is that happening? On the cellular level, we have an energy deficit in the sodium-potassium-ATPase pump of the neurons themselves.

Dr. Wilner: Suppose you do see diffuse axonal injury; does that take it out of concussion, or can you have a concussion with visible injury?

Dr. Datta: I think you can have overlap in the symptoms. The diffuse axonal injury would put it into a higher grade of head injury as opposed to a mild traumatic brain injury. Definitely, we would need to work together with our trauma doctors to ensure that patients are not on blood thinners or anything until they heal well enough. Obviously, I would pick them up as an outpatient and follow them until we resolve or rehab them as best as possible.

Concussion assessment tools

Dr. Wilner: There are many sports out there where concussions are fairly frequent, like American football and hockey, for example. Are there any statements in the new guidelines?

Dr. Datta: There are no statements for or against a particular sport because that would really make too much of a bold statement about cause and effect. There is a cause and effect in long-term, repetitive exposure, I would say, in terms of someone being able to play or sustain injury.

Right now, at least at the concussion conference I went to and in the upcoming consensus statement, they will not comment on a specific sport. Obviously, we know that the higher-impact sports are a little more dangerous.

Let’s be honest. At the high school, middle school, or even younger level, some kids are not necessarily the most athletic, right? They play because their friends are playing. If they’re repeatedly getting injured, it’s time for an astute clinician, or a coach, and a whole team to assess them to see if maybe this person is just going to continue to get hurt if they’re not taken out of the game and perhaps they should go to a lower-impact sport.

Dr. Wilner: In schools, often there’s a big size and weight difference. There are 14-year-olds who are 6 fett 2 inches and 200 pounds, and there are 14-year-olds who are 5 feet 2 inches and 110 pounds. Obviously, they’re mismatched on the football field.

You mentioned coaches. Is there anything in the guidelines about training coaches?

Dr. Datta: Specifically, there was nothing in the guidelines about that. There’s a tool for coaches at every level to use, which is called the Sports Concussion Assessment Tool, or SCAT, which is going to be updated to the SCAT6. At the NCAA level, they must receive annual training on concussion management and be given an NCAA concussion handout for coaches.

Obviously, there are more rigorous protocols for national-level coaching. As it stands now, it is not mandatory, but they are given tools to assess someone once they’ve gotten a hit to take them out of the game.

Dr. Wilner: I’ve been following the concussion research through the years. They did some neuropsychological testing on athletes who’ve had this many concussions or that many concussions, and they would find deficits here or subtle deficits there, but they had no baseline.

Then, there was a movement to start testing athletes before the season starts so that they could do a repeat test after concussion and see if there is any difference. Is that something we’re recommending?

Dr. Datta: Most of the time, NCAA-level – certainly where I trained – and national-level sports do testing, but it’s not everywhere. Prior guidelines have indicated that preseason testing is not required. That is largely because there has been no standardized neuropsychological testing established.

There are computerized testing options where the validity and reliability are questionable. Also, let’s say it’s a college student; they didn’t sleep all night and then they took this computer test. They would probably do worse than they would if they had received a head hit.

Just to be on the safe side, most places that have collegiate-level sports that are at a high level do preseason testing. If I were to speak personally, aside from the guidelines, I would say that it’s been helpful for me to look at the before and after, in general, overall, to make a decision about my treatment protocol.

Dr. Wilner: Let’s talk about the patient. You have a 20-year-old guy. He’s playing football. There’s a big play. Bonk, he gets hit on the head. He’s on the ground. He’s dazed, staggers a little bit, gets up, and you ask how he is feeling. He says he’s fine and then he wobbles off to the sideline. What do you do with that kid?

Dr. Datta: Obviously, the first thing is to remove him from the play environment to a quiet space. Second, either an athletic trainer or a coach would administer basic screening neurologic tests, such as “where are you, what’s today’s date, what is your name?” and other orientation questions.

They’ll also go through the SCAT – that’ll be SCAT6 starting in July – the SCAT5 symptom questionnaire to see what symptoms they have. Often, they’re using sideline testing software.

There are two things that can be used on a card to test eye movements, to see if they’re slower. They come out of NYU, coincidentally – the Memory Image Completion (MIC) and the Mobile Universal Lexicon Evaluation System (MULES) – and are used to determine whether eye movements are slower. That way, you can tell whether someone is, compared with before they got their head hit, slower than before.

Based on this composite information, usually the teammates and the head people on the team will know if a player looks different.

They need to be taken out, obviously, if there is nausea or vomiting, any neurologic signs and symptoms, or a neck injury that needs to be stabilized. ABCs first, right? If there’s any vomiting or seizures, they should be taken to the ER right away.

The first thing is to take them out, then do a sideline assessment. Third, see if they need to immediately go to the ED versus follow-up outpatient with me within a day or two.

Dr. Wilner: I think it’s the subtle injuries that are the tough ones. Back to our 20-year-old. He says: “Oh, I’m fine. I want to go back in the game.” Everybody can tell he’s not quite right, even though he passed all the tests. What do you do then?

Dr. Datta: You have to make a judgment call for the safety of the player. They always want to go back, right? This is also an issue when they’re competing for college scholarships and things of that nature. Sometimes they’re sandbagging, where they memorize the answers.

Everything’s on the Internet nowadays, right? We have to make a judgment call as members of the healthcare community and the sports community to keep that player safe.

Just keep them out. Don’t bring them back in the game. Keep them out for a reasonable amount of time. There’s a test called the Buffalo Concussion Treadmill Test; Dr. John Leddy from University of Buffalo has developed a way for us to put athletes through a screening protocol.

This can be part of their vestibular and ocular rehabilitation, where if they don’t have symptoms when we bring their heart rate to certain levels, then we can slowly clear them for return to play as long as they’re nonsymptomatic.

Dr. Wilner: I spoke with your colleague, Dr. Riggins, who is also on your panel, and we were talking about when they can go back. She said they can go back when they don’t have any symptoms. No more headache, no more dizziness, no more lightheadedness, no more trouble concentrating or with memory – all those things have gone away.

Sometimes these symptoms are stubborn. If you have, say, 100 patients like our 20-year-old who got bonked on the head, has some headaches, and doesn’t feel quite right, what usually happens? How many are back to play the next day, the next week, or the next month? How many are out for the season? How does that play out?

Dr. Datta: It depends on a couple of different factors. One, have they had previous head injuries? Two, do they have preexisting symptoms or signs, or diagnoses like migraines, which are likely to get worse after a head injury? Anything that’s preexisting, like a mood disorder, anxiety, depression, or trouble sleeping, is going to get worse.

If they were compensating for untreated ADD or borderline personality or bipolar, I’ve seen many people who’ve developed them. These are not the norm, but I’m saying that you have to be very careful.

Getting back to the question, you treat them. Reasonably, if they’re healthy and they don’t have preexisting signs and symptoms, I would say more than half are back in about 2 weeks.. I would say 60%-70%. It all depends. If they have preexisting issues, then it’s going to take much longer.
 

From SCAT to SCOAT

Dr. Wilner: This has been very informative. Before we wrap up, tell us what to expect from these guidelines in July. How are they really going to help?

Dr. Datta: The consensus statement is going to come out with something called a SCOAT, which stands for Sport Concussion Office Assessment Tool. We’ve been using the SCAT, which was meant for more sideline assessment because that’s all we had, and it’s worked perfectly well.

This will be better because we often see them within 24-48 hours, when the symptoms are sometimes a little bit better.

We also will see the sport and concussion group come up with added athlete perspectives, ethics discussion, power-sport athlete considerations, and development of this new SCOAT.

Dr. Wilner: Dr. Datta, this is very exciting. I look forward to reading these guidelines in July. I want to thank you for your hard work. I also look forward to talking to you at next year’s meeting. Thank you very much for giving us this update.

Dr. Datta: No problem. It’s my pleasure.

A version of this article originally appeared on Medscape.com.

This transcript has been edited for clarity.

Andrew N. Wilner, MD: I’m your host, Dr. Andrew Wilner, reporting virtually from the 2023 American Academy of Neurology meeting in Boston. It’s my pleasure today to speak with Dr. Shae Datta, codirector of the NYU Langone Concussion Center.

She’s also a clinical assistant professor of neurology at NYU School of Medicine. Dr. Datta is chair of the AAN Sports Neurology Section, and she’s leading a panel on concussion at this year’s meeting. She’s going to give us an update. Welcome, Dr. Datta.

Shae Datta, MD: Thank you so much, Andrew. I really love the fact that I’m here speaking to you about all of the new, exciting developments in the field.

Dr. Wilner: Before we get too deep, tell us how you got interested in this topic.

Dr. Datta: I initially thought, when I was in training as a resident, that I wanted to do something like neurocritical care or EEG. It also puzzled me why these seemingly smaller head injuries that didn’t end up in the hospital or ICU were bounced from neurology headache clinic to neuro-ophthalmology headache clinic to neurovestibular headache clinic, and nobody seemed to be able to put together the dots about why they’re having so many different issues — but at the same time, nobody could help them.

At that time, this field was very new. I was on a plane to Paris to a neurocritical care conference as a resident, and I saw the movie Concussion with Will Smith.

It featured one of my current mentors who taught at the fellowship that I graduated from, and it was a fascinating field. I just started looking deeply into it, and I saw that there was a new training fellowship for sports neurology and concussion management, and this is basically why we’re here today.
 

New concussion consensus guidelines coming

Dr. Wilner: I think this field has really exploded. It used to be that you banged your head, you did a CT scan – remember, I trained about 45 years ago – and if there was nothing on the CT scan, you were done. If you had headaches, you took Tylenol until they went away.

Now, we do MRI, and we realized that it’s really a syndrome. I understand that there are going to be some formal guidelines that have been put together. Is that correct?

Dr. Datta: That’s correct. The 6th International Consensus Conference on Concussion in Sport, in Amsterdam, where I attended and presented a poster, was really a meeting of all the best minds – clinicians and researchers in brain injury – to form a consensus on the newest guidelines that are going to direct our treatment going forward.

Dr. Wilner: I’m going to ask you a trick question because the last time I looked it up I did not get a satisfying answer. What is a concussion?

Dr. Datta: That’s a very good question, and everyone always asks. A concussion is an external force that is emitted upon the head or the neck, or the body, in general, that may cause temporary loss of function. It’s a functional problem.

We don’t see much on CT. We can do MRI. We can do SPECT or we can do these very fancy images, sometimes, of high-velocity head injuries and see small microhemorrhages.

Often, we don’t see anything, but still the patient is loopy. They can’t see straight. They are double-visioned. They have vertigo. Why is that happening? On the cellular level, we have an energy deficit in the sodium-potassium-ATPase pump of the neurons themselves.

Dr. Wilner: Suppose you do see diffuse axonal injury; does that take it out of concussion, or can you have a concussion with visible injury?

Dr. Datta: I think you can have overlap in the symptoms. The diffuse axonal injury would put it into a higher grade of head injury as opposed to a mild traumatic brain injury. Definitely, we would need to work together with our trauma doctors to ensure that patients are not on blood thinners or anything until they heal well enough. Obviously, I would pick them up as an outpatient and follow them until we resolve or rehab them as best as possible.

Concussion assessment tools

Dr. Wilner: There are many sports out there where concussions are fairly frequent, like American football and hockey, for example. Are there any statements in the new guidelines?

Dr. Datta: There are no statements for or against a particular sport because that would really make too much of a bold statement about cause and effect. There is a cause and effect in long-term, repetitive exposure, I would say, in terms of someone being able to play or sustain injury.

Right now, at least at the concussion conference I went to and in the upcoming consensus statement, they will not comment on a specific sport. Obviously, we know that the higher-impact sports are a little more dangerous.

Let’s be honest. At the high school, middle school, or even younger level, some kids are not necessarily the most athletic, right? They play because their friends are playing. If they’re repeatedly getting injured, it’s time for an astute clinician, or a coach, and a whole team to assess them to see if maybe this person is just going to continue to get hurt if they’re not taken out of the game and perhaps they should go to a lower-impact sport.

Dr. Wilner: In schools, often there’s a big size and weight difference. There are 14-year-olds who are 6 fett 2 inches and 200 pounds, and there are 14-year-olds who are 5 feet 2 inches and 110 pounds. Obviously, they’re mismatched on the football field.

You mentioned coaches. Is there anything in the guidelines about training coaches?

Dr. Datta: Specifically, there was nothing in the guidelines about that. There’s a tool for coaches at every level to use, which is called the Sports Concussion Assessment Tool, or SCAT, which is going to be updated to the SCAT6. At the NCAA level, they must receive annual training on concussion management and be given an NCAA concussion handout for coaches.

Obviously, there are more rigorous protocols for national-level coaching. As it stands now, it is not mandatory, but they are given tools to assess someone once they’ve gotten a hit to take them out of the game.

Dr. Wilner: I’ve been following the concussion research through the years. They did some neuropsychological testing on athletes who’ve had this many concussions or that many concussions, and they would find deficits here or subtle deficits there, but they had no baseline.

Then, there was a movement to start testing athletes before the season starts so that they could do a repeat test after concussion and see if there is any difference. Is that something we’re recommending?

Dr. Datta: Most of the time, NCAA-level – certainly where I trained – and national-level sports do testing, but it’s not everywhere. Prior guidelines have indicated that preseason testing is not required. That is largely because there has been no standardized neuropsychological testing established.

There are computerized testing options where the validity and reliability are questionable. Also, let’s say it’s a college student; they didn’t sleep all night and then they took this computer test. They would probably do worse than they would if they had received a head hit.

Just to be on the safe side, most places that have collegiate-level sports that are at a high level do preseason testing. If I were to speak personally, aside from the guidelines, I would say that it’s been helpful for me to look at the before and after, in general, overall, to make a decision about my treatment protocol.

Dr. Wilner: Let’s talk about the patient. You have a 20-year-old guy. He’s playing football. There’s a big play. Bonk, he gets hit on the head. He’s on the ground. He’s dazed, staggers a little bit, gets up, and you ask how he is feeling. He says he’s fine and then he wobbles off to the sideline. What do you do with that kid?

Dr. Datta: Obviously, the first thing is to remove him from the play environment to a quiet space. Second, either an athletic trainer or a coach would administer basic screening neurologic tests, such as “where are you, what’s today’s date, what is your name?” and other orientation questions.

They’ll also go through the SCAT – that’ll be SCAT6 starting in July – the SCAT5 symptom questionnaire to see what symptoms they have. Often, they’re using sideline testing software.

There are two things that can be used on a card to test eye movements, to see if they’re slower. They come out of NYU, coincidentally – the Memory Image Completion (MIC) and the Mobile Universal Lexicon Evaluation System (MULES) – and are used to determine whether eye movements are slower. That way, you can tell whether someone is, compared with before they got their head hit, slower than before.

Based on this composite information, usually the teammates and the head people on the team will know if a player looks different.

They need to be taken out, obviously, if there is nausea or vomiting, any neurologic signs and symptoms, or a neck injury that needs to be stabilized. ABCs first, right? If there’s any vomiting or seizures, they should be taken to the ER right away.

The first thing is to take them out, then do a sideline assessment. Third, see if they need to immediately go to the ED versus follow-up outpatient with me within a day or two.

Dr. Wilner: I think it’s the subtle injuries that are the tough ones. Back to our 20-year-old. He says: “Oh, I’m fine. I want to go back in the game.” Everybody can tell he’s not quite right, even though he passed all the tests. What do you do then?

Dr. Datta: You have to make a judgment call for the safety of the player. They always want to go back, right? This is also an issue when they’re competing for college scholarships and things of that nature. Sometimes they’re sandbagging, where they memorize the answers.

Everything’s on the Internet nowadays, right? We have to make a judgment call as members of the healthcare community and the sports community to keep that player safe.

Just keep them out. Don’t bring them back in the game. Keep them out for a reasonable amount of time. There’s a test called the Buffalo Concussion Treadmill Test; Dr. John Leddy from University of Buffalo has developed a way for us to put athletes through a screening protocol.

This can be part of their vestibular and ocular rehabilitation, where if they don’t have symptoms when we bring their heart rate to certain levels, then we can slowly clear them for return to play as long as they’re nonsymptomatic.

Dr. Wilner: I spoke with your colleague, Dr. Riggins, who is also on your panel, and we were talking about when they can go back. She said they can go back when they don’t have any symptoms. No more headache, no more dizziness, no more lightheadedness, no more trouble concentrating or with memory – all those things have gone away.

Sometimes these symptoms are stubborn. If you have, say, 100 patients like our 20-year-old who got bonked on the head, has some headaches, and doesn’t feel quite right, what usually happens? How many are back to play the next day, the next week, or the next month? How many are out for the season? How does that play out?

Dr. Datta: It depends on a couple of different factors. One, have they had previous head injuries? Two, do they have preexisting symptoms or signs, or diagnoses like migraines, which are likely to get worse after a head injury? Anything that’s preexisting, like a mood disorder, anxiety, depression, or trouble sleeping, is going to get worse.

If they were compensating for untreated ADD or borderline personality or bipolar, I’ve seen many people who’ve developed them. These are not the norm, but I’m saying that you have to be very careful.

Getting back to the question, you treat them. Reasonably, if they’re healthy and they don’t have preexisting signs and symptoms, I would say more than half are back in about 2 weeks.. I would say 60%-70%. It all depends. If they have preexisting issues, then it’s going to take much longer.
 

From SCAT to SCOAT

Dr. Wilner: This has been very informative. Before we wrap up, tell us what to expect from these guidelines in July. How are they really going to help?

Dr. Datta: The consensus statement is going to come out with something called a SCOAT, which stands for Sport Concussion Office Assessment Tool. We’ve been using the SCAT, which was meant for more sideline assessment because that’s all we had, and it’s worked perfectly well.

This will be better because we often see them within 24-48 hours, when the symptoms are sometimes a little bit better.

We also will see the sport and concussion group come up with added athlete perspectives, ethics discussion, power-sport athlete considerations, and development of this new SCOAT.

Dr. Wilner: Dr. Datta, this is very exciting. I look forward to reading these guidelines in July. I want to thank you for your hard work. I also look forward to talking to you at next year’s meeting. Thank you very much for giving us this update.

Dr. Datta: No problem. It’s my pleasure.

A version of this article originally appeared on Medscape.com.

Tuesdays and Fridays are tough. Not so much because of clinic, but rather because of the 32 minutes before clinic that I’m on the Peloton bike. They are the mornings I dedicate to training VO_2max. 

Training VO_2max, or maximal oxygen consumption, is simple. Spin for a leisurely, easy-breathing, 4 minutes, then for 4 minutes push yourself until you see the light of heaven and wish for death to come. Then relax for 4 minutes again. Repeat this cycle four to six times. Done justly, you will dread Tuesdays and Fridays too. The punishing cycle of a 4-minute push, then 4-minute recovery is, however, an excellent way to improve cardiovascular fitness. And no, I’m not training for the Boston Marathon, so why am I working so hard? Because I’m training for marathon clinic days for the next 20 years.

Now more than ever, I feel we have to be physically fit to deal with a physicians’ day’s work. By the time the last patient leaves, I’m beat. From the first bell, patients are packed in, our in boxes are overflowing with messages, pathology results are piling up. It’s exhausting. The root cause is too much work, yes, but I believe being physically fit could help. 

I was talking to an 86-year-old patient about this very topic recently. He was short, with a well-manicured goatee and shiny head. He stuck his arm out to shake my hand. “Glad we’re back to handshakes again, doc.” His grip was that of a 30-year-old. “Buff” you’d likely describe him: He is noticeably muscular, not a skinny old man. He’s an old Navy Master Chief who started a business in wholesale flowers, which distributes all over the United States. And he’s still working full time. Impressed, I asked his secret for such vigor. PT, he replied. 

PT, or physical training, is a foundational element of the Navy. Every sailor starts his or her day with morning PT before carrying out their duties. Some 30 years later, this guy is still getting after it. He does push-ups, sit-ups, and pull-ups nearly every morning. Morning PT is what he attributes to his success not only in health, but also business. As he sees it, he has the business savvy and experience of an old guy and the energy and stamina of a college kid. A good combination for a successful life.

I’ve always been pretty fit. Lately, I’ve been trying to take it to the next level, to not just be “physically active,” but rather “high-performance fit.” There are plenty of sources for instruction; how to stay young and healthy isn’t a new idea after all. I mean, Herodotus wrote of finding the Fountain of Youth in the 5th century BCE. A couple thousand years later, it’s still on trend. One of my favorite sages giving health span advice is Peter Attia, MD. I’ve been a fan since I met him at TEDMED in 2013 and I marvel at the astounding body of work he has created since. A Johns Hopkins–trained surgeon, he has spent his career reviewing the scientific literature about longevity and sharing it as actionable content. His book, “Outlive: The Science and Art of Longevity” (New York: Penguin Random House, 2023) is a nice summary of his work. I recommend it. 

Right now I’m switching between type 2 muscle fiber work (lots of jumping like my 2-year-old) and cardiovascular training including the aforementioned VO_2max work. I cannot say that my patient inbox is any cleaner, or that I’m faster in the office, but I’m not flagging by the end of the day anymore. Master Chief challenged me to match his 10 pull-ups before he returns for his follow up visit. I’ll gladly give up Peloton sprints to work on that.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Tuesdays and Fridays are tough. Not so much because of clinic, but rather because of the 32 minutes before clinic that I’m on the Peloton bike. They are the mornings I dedicate to training VO_2max. 

Training VO_2max, or maximal oxygen consumption, is simple. Spin for a leisurely, easy-breathing, 4 minutes, then for 4 minutes push yourself until you see the light of heaven and wish for death to come. Then relax for 4 minutes again. Repeat this cycle four to six times. Done justly, you will dread Tuesdays and Fridays too. The punishing cycle of a 4-minute push, then 4-minute recovery is, however, an excellent way to improve cardiovascular fitness. And no, I’m not training for the Boston Marathon, so why am I working so hard? Because I’m training for marathon clinic days for the next 20 years.

Now more than ever, I feel we have to be physically fit to deal with a physicians’ day’s work. By the time the last patient leaves, I’m beat. From the first bell, patients are packed in, our in boxes are overflowing with messages, pathology results are piling up. It’s exhausting. The root cause is too much work, yes, but I believe being physically fit could help. 

I was talking to an 86-year-old patient about this very topic recently. He was short, with a well-manicured goatee and shiny head. He stuck his arm out to shake my hand. “Glad we’re back to handshakes again, doc.” His grip was that of a 30-year-old. “Buff” you’d likely describe him: He is noticeably muscular, not a skinny old man. He’s an old Navy Master Chief who started a business in wholesale flowers, which distributes all over the United States. And he’s still working full time. Impressed, I asked his secret for such vigor. PT, he replied. 

PT, or physical training, is a foundational element of the Navy. Every sailor starts his or her day with morning PT before carrying out their duties. Some 30 years later, this guy is still getting after it. He does push-ups, sit-ups, and pull-ups nearly every morning. Morning PT is what he attributes to his success not only in health, but also business. As he sees it, he has the business savvy and experience of an old guy and the energy and stamina of a college kid. A good combination for a successful life.

I’ve always been pretty fit. Lately, I’ve been trying to take it to the next level, to not just be “physically active,” but rather “high-performance fit.” There are plenty of sources for instruction; how to stay young and healthy isn’t a new idea after all. I mean, Herodotus wrote of finding the Fountain of Youth in the 5th century BCE. A couple thousand years later, it’s still on trend. One of my favorite sages giving health span advice is Peter Attia, MD. I’ve been a fan since I met him at TEDMED in 2013 and I marvel at the astounding body of work he has created since. A Johns Hopkins–trained surgeon, he has spent his career reviewing the scientific literature about longevity and sharing it as actionable content. His book, “Outlive: The Science and Art of Longevity” (New York: Penguin Random House, 2023) is a nice summary of his work. I recommend it. 

Right now I’m switching between type 2 muscle fiber work (lots of jumping like my 2-year-old) and cardiovascular training including the aforementioned VO_2max work. I cannot say that my patient inbox is any cleaner, or that I’m faster in the office, but I’m not flagging by the end of the day anymore. Master Chief challenged me to match his 10 pull-ups before he returns for his follow up visit. I’ll gladly give up Peloton sprints to work on that.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Tuesdays and Fridays are tough. Not so much because of clinic, but rather because of the 32 minutes before clinic that I’m on the Peloton bike. They are the mornings I dedicate to training VO_2max. 

Training VO_2max, or maximal oxygen consumption, is simple. Spin for a leisurely, easy-breathing, 4 minutes, then for 4 minutes push yourself until you see the light of heaven and wish for death to come. Then relax for 4 minutes again. Repeat this cycle four to six times. Done justly, you will dread Tuesdays and Fridays too. The punishing cycle of a 4-minute push, then 4-minute recovery is, however, an excellent way to improve cardiovascular fitness. And no, I’m not training for the Boston Marathon, so why am I working so hard? Because I’m training for marathon clinic days for the next 20 years.

Now more than ever, I feel we have to be physically fit to deal with a physicians’ day’s work. By the time the last patient leaves, I’m beat. From the first bell, patients are packed in, our in boxes are overflowing with messages, pathology results are piling up. It’s exhausting. The root cause is too much work, yes, but I believe being physically fit could help. 

I was talking to an 86-year-old patient about this very topic recently. He was short, with a well-manicured goatee and shiny head. He stuck his arm out to shake my hand. “Glad we’re back to handshakes again, doc.” His grip was that of a 30-year-old. “Buff” you’d likely describe him: He is noticeably muscular, not a skinny old man. He’s an old Navy Master Chief who started a business in wholesale flowers, which distributes all over the United States. And he’s still working full time. Impressed, I asked his secret for such vigor. PT, he replied. 

PT, or physical training, is a foundational element of the Navy. Every sailor starts his or her day with morning PT before carrying out their duties. Some 30 years later, this guy is still getting after it. He does push-ups, sit-ups, and pull-ups nearly every morning. Morning PT is what he attributes to his success not only in health, but also business. As he sees it, he has the business savvy and experience of an old guy and the energy and stamina of a college kid. A good combination for a successful life.

I’ve always been pretty fit. Lately, I’ve been trying to take it to the next level, to not just be “physically active,” but rather “high-performance fit.” There are plenty of sources for instruction; how to stay young and healthy isn’t a new idea after all. I mean, Herodotus wrote of finding the Fountain of Youth in the 5th century BCE. A couple thousand years later, it’s still on trend. One of my favorite sages giving health span advice is Peter Attia, MD. I’ve been a fan since I met him at TEDMED in 2013 and I marvel at the astounding body of work he has created since. A Johns Hopkins–trained surgeon, he has spent his career reviewing the scientific literature about longevity and sharing it as actionable content. His book, “Outlive: The Science and Art of Longevity” (New York: Penguin Random House, 2023) is a nice summary of his work. I recommend it. 

Right now I’m switching between type 2 muscle fiber work (lots of jumping like my 2-year-old) and cardiovascular training including the aforementioned VO_2max work. I cannot say that my patient inbox is any cleaner, or that I’m faster in the office, but I’m not flagging by the end of the day anymore. Master Chief challenged me to match his 10 pull-ups before he returns for his follow up visit. I’ll gladly give up Peloton sprints to work on that.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

A new study urges people to continue wearing protective masks in medical settings, even though the U.S. public health emergency declaration around COVID-19 has expired.

Masks continue to lower the risk of catching the virus during medical visits, according to the study, published in Annals of Internal Medicine. And there was not much difference between wearing surgical masks and N95 respirators in health care settings.

The researchers reviewed 3 randomized trials and 21 observational studies to compare the effectiveness of those and cloth masks in reducing COVID-19 transmission.

“Masking in interactions between patients and health care personnel should continue to receive serious consideration as a patient safety measure,” Tara N. Palmore, MD, of George Washington University, Washington, and David K. Henderson, MD, of the National Institutes of Health, Bethesda, Md., wrote in an opinion article accompanying the study.

“In our enthusiasm to return to the appearance and feeling of normalcy, and as institutions decide which mitigation strategies to discontinue, we strongly advocate not discarding this important lesson learned for the sake of our patients’ safety,” Dr. Palmore and Dr. Henderson wrote.

Surgical masks limit the spread of aerosols and droplets from people who have the flu, coronaviruses or other respiratory viruses, CNN reported. And while masks are not 100% effective, they substantially lower the amount of virus put into the air via coughing and talking.

The study said one reason people should wear masks to medical settings is because “health care personnel are notorious for coming to work while ill.” Transmission from patient to staff and staff to patient is still possible, but rare, when both are masked.

The review authors reported no conflicts of interest. Dr. Palmore has received grants from the NIH, Rigel, Gilead, and AbbVie, and Dr. Henderson is a past president of the Society for Healthcare Epidemiology of America.

A version of this article first appeared on WebMD.com.

A new study urges people to continue wearing protective masks in medical settings, even though the U.S. public health emergency declaration around COVID-19 has expired.

Masks continue to lower the risk of catching the virus during medical visits, according to the study, published in Annals of Internal Medicine. And there was not much difference between wearing surgical masks and N95 respirators in health care settings.

The researchers reviewed 3 randomized trials and 21 observational studies to compare the effectiveness of those and cloth masks in reducing COVID-19 transmission.

“Masking in interactions between patients and health care personnel should continue to receive serious consideration as a patient safety measure,” Tara N. Palmore, MD, of George Washington University, Washington, and David K. Henderson, MD, of the National Institutes of Health, Bethesda, Md., wrote in an opinion article accompanying the study.

“In our enthusiasm to return to the appearance and feeling of normalcy, and as institutions decide which mitigation strategies to discontinue, we strongly advocate not discarding this important lesson learned for the sake of our patients’ safety,” Dr. Palmore and Dr. Henderson wrote.

Surgical masks limit the spread of aerosols and droplets from people who have the flu, coronaviruses or other respiratory viruses, CNN reported. And while masks are not 100% effective, they substantially lower the amount of virus put into the air via coughing and talking.

The study said one reason people should wear masks to medical settings is because “health care personnel are notorious for coming to work while ill.” Transmission from patient to staff and staff to patient is still possible, but rare, when both are masked.

The review authors reported no conflicts of interest. Dr. Palmore has received grants from the NIH, Rigel, Gilead, and AbbVie, and Dr. Henderson is a past president of the Society for Healthcare Epidemiology of America.

A version of this article first appeared on WebMD.com.

A new study urges people to continue wearing protective masks in medical settings, even though the U.S. public health emergency declaration around COVID-19 has expired.

Masks continue to lower the risk of catching the virus during medical visits, according to the study, published in Annals of Internal Medicine. And there was not much difference between wearing surgical masks and N95 respirators in health care settings.

The researchers reviewed 3 randomized trials and 21 observational studies to compare the effectiveness of those and cloth masks in reducing COVID-19 transmission.

“Masking in interactions between patients and health care personnel should continue to receive serious consideration as a patient safety measure,” Tara N. Palmore, MD, of George Washington University, Washington, and David K. Henderson, MD, of the National Institutes of Health, Bethesda, Md., wrote in an opinion article accompanying the study.

“In our enthusiasm to return to the appearance and feeling of normalcy, and as institutions decide which mitigation strategies to discontinue, we strongly advocate not discarding this important lesson learned for the sake of our patients’ safety,” Dr. Palmore and Dr. Henderson wrote.

Surgical masks limit the spread of aerosols and droplets from people who have the flu, coronaviruses or other respiratory viruses, CNN reported. And while masks are not 100% effective, they substantially lower the amount of virus put into the air via coughing and talking.

The study said one reason people should wear masks to medical settings is because “health care personnel are notorious for coming to work while ill.” Transmission from patient to staff and staff to patient is still possible, but rare, when both are masked.

The review authors reported no conflicts of interest. Dr. Palmore has received grants from the NIH, Rigel, Gilead, and AbbVie, and Dr. Henderson is a past president of the Society for Healthcare Epidemiology of America.

A version of this article first appeared on WebMD.com.

Fastest peptide north, south, east, aaaaand west of the Pecos

Bacterial infections are supposed to be simple. You get infected, you get an antibiotic to treat it. Easy. Some bacteria, though, don’t play by the rules. Those antibiotics may kill 99.9% of germs, but what about the 0.1% that gets left behind? With their fallen comrades out of the way, the accidentally drug resistant species are free to inherit the Earth.

Antibiotic resistance is thus a major concern for the medical community. Naturally, anything that prevents doctors from successfully curing sick people is a priority. Unless you’re a major pharmaceutical company that has been loath to develop new drugs that can beat antibiotic-resistant bacteria. Blah blah, time and money, blah blah, long time between development and market application, blah blah, no profit. We all know the story with pharmaceutical companies.

Ilana Camargo

Research from other sources has continued, however, and Brazilian scientists recently published research involving a peptide known as plantaricin 149. This peptide, derived from the bacterium Lactobacillus plantarum, has been known for nearly 30 years to have antibacterial properties. Pln149 in its natural state, though, is not particularly efficient at bacteria-killing. Fortunately, we have science and technology on our side.

The researchers synthesized 20 analogs of Pln149, of which Pln149-PEP20 had the best results. The elegantly named compound is less than half the size of the original peptide, less toxic, and far better at killing any and all drug-resistant bacteria the researchers threw at it. How much better? Pln149-PEP20 started killing bacteria less than an hour after being introduced in lab trials.

The research is just in its early days – just because something is less toxic doesn’t necessarily mean you want to go and help yourself to it – but we can only hope that those lovely pharmaceutical companies deign to look down upon us and actually develop a drug utilizing Pln149-PEP20 to, you know, actually help sick people, instead of trying to build monopolies or avoiding paying billions in taxes. Yeah, we couldn’t keep a straight face through that last sentence either.
 

Speed healing: The wavy wound gets the swirl

Did you know that wavy wounds heal faster than straight wounds? Well, we didn’t, but apparently quite a few people did, because somebody has been trying to figure out why wavy wounds heal faster than straight ones. Do the surgeons know about this? How about you dermatologists? Wavy over straight? We’re the media. We’re supposed to report this kind of stuff. Maybe hit us with a tweet next time you do something important, or push a TikTok our way, okay?

You could be more like the investigators at Nanyang Technological University in Singapore, who figured out the why and then released a statement about it.

NTU Singapore

They created synthetic wounds – some straight, some wavy – in micropatterned hydrogel substrates that mimicked human skin. Then they used an advanced optical technique known as particle image velocimetry to measure fluid flow and learn how cells moved to close the wound gaps.

The wavy wounds “induced more complex collective cell movements, such as a swirly, vortex-like motion,” according to the written statement from NTU Singapore. In the straight wounds, cell movements paralleled the wound front, “moving in straight lines like a marching band,” they pointed out, unlike some researchers who never call us unless they need money.

Complex epithelial cell movements are better, it turns out. Over an observation period of 64 hours the NTU team found that the healing efficiency of wavy gaps – measured by the area covered by the cells over time – is nearly five times faster than straight gaps.

The complex motion “enabled cells to quickly connect with similar cells on the opposite site of the wound edge, forming a bridge and closing the wavy wound gaps faster than straight gaps,” explained lead author Xu Hongmei, a doctoral student at NTU’s School of Mechanical and Aerospace Engineering, who seems to have time to toss out a tumblr or two to keep the press informed.

As for the rest of you, would it kill you to pick up a phone once in a while? Maybe let a journalist know that you’re still alive? We have feelings too, you know, and we worry.
 

A little Jekyll, a little Hyde, and a little shop of horrors

More “Little Shop of Horrors” references are coming, so be prepared.

We begin with Triphyophyllum peltatum. This woody vine is of great interest to medical and pharmaceutical researchers because its constituents have shown promise against pancreatic cancer and leukemia cells, among others, along with the pathogens that cause malaria and other diseases. There is another side, however. T. peltatum also has a tendency to turn into a realistic Audrey II when deprived.

No, of course they’re not craving human flesh, but it does become … carnivorous in its appetite.

T. peltatum, native to the West African tropics and not found in a New York florist shop, has the unique ability to change its diet and development based on the environmental circumstances. For some unknown reason, the leaves would develop adhesive traps in the form of sticky drops that capture insect prey. The plant is notoriously hard to grow, however, so no one could study the transformation under lab conditions. Until now.

Traud Winkelmann/University of Hannover

A group of German scientists “exposed the plant to different stress factors, including deficiencies of various nutrients, and studied how it responded to each,” said Dr. Traud Winkelmann of Leibniz University Hannover. “Only in one case were we able to observe the formation of traps: in the case of a lack of phosphorus.”

Well, there you have it: phosphorus. We need it for healthy bones and teeth, which this plant doesn’t have to worry about, unlike its Tony Award–nominated counterpart. The investigators hope that their findings could lead to “future molecular analyses that will help understand the origins of carnivory,” but we’re guessing that a certain singing alien species will be left out of that research.

Fastest peptide north, south, east, aaaaand west of the Pecos

Bacterial infections are supposed to be simple. You get infected, you get an antibiotic to treat it. Easy. Some bacteria, though, don’t play by the rules. Those antibiotics may kill 99.9% of germs, but what about the 0.1% that gets left behind? With their fallen comrades out of the way, the accidentally drug resistant species are free to inherit the Earth.

Antibiotic resistance is thus a major concern for the medical community. Naturally, anything that prevents doctors from successfully curing sick people is a priority. Unless you’re a major pharmaceutical company that has been loath to develop new drugs that can beat antibiotic-resistant bacteria. Blah blah, time and money, blah blah, long time between development and market application, blah blah, no profit. We all know the story with pharmaceutical companies.

Ilana Camargo

Research from other sources has continued, however, and Brazilian scientists recently published research involving a peptide known as plantaricin 149. This peptide, derived from the bacterium Lactobacillus plantarum, has been known for nearly 30 years to have antibacterial properties. Pln149 in its natural state, though, is not particularly efficient at bacteria-killing. Fortunately, we have science and technology on our side.

The researchers synthesized 20 analogs of Pln149, of which Pln149-PEP20 had the best results. The elegantly named compound is less than half the size of the original peptide, less toxic, and far better at killing any and all drug-resistant bacteria the researchers threw at it. How much better? Pln149-PEP20 started killing bacteria less than an hour after being introduced in lab trials.

The research is just in its early days – just because something is less toxic doesn’t necessarily mean you want to go and help yourself to it – but we can only hope that those lovely pharmaceutical companies deign to look down upon us and actually develop a drug utilizing Pln149-PEP20 to, you know, actually help sick people, instead of trying to build monopolies or avoiding paying billions in taxes. Yeah, we couldn’t keep a straight face through that last sentence either.
 

Speed healing: The wavy wound gets the swirl

Did you know that wavy wounds heal faster than straight wounds? Well, we didn’t, but apparently quite a few people did, because somebody has been trying to figure out why wavy wounds heal faster than straight ones. Do the surgeons know about this? How about you dermatologists? Wavy over straight? We’re the media. We’re supposed to report this kind of stuff. Maybe hit us with a tweet next time you do something important, or push a TikTok our way, okay?

You could be more like the investigators at Nanyang Technological University in Singapore, who figured out the why and then released a statement about it.

NTU Singapore

They created synthetic wounds – some straight, some wavy – in micropatterned hydrogel substrates that mimicked human skin. Then they used an advanced optical technique known as particle image velocimetry to measure fluid flow and learn how cells moved to close the wound gaps.

The wavy wounds “induced more complex collective cell movements, such as a swirly, vortex-like motion,” according to the written statement from NTU Singapore. In the straight wounds, cell movements paralleled the wound front, “moving in straight lines like a marching band,” they pointed out, unlike some researchers who never call us unless they need money.

Complex epithelial cell movements are better, it turns out. Over an observation period of 64 hours the NTU team found that the healing efficiency of wavy gaps – measured by the area covered by the cells over time – is nearly five times faster than straight gaps.

The complex motion “enabled cells to quickly connect with similar cells on the opposite site of the wound edge, forming a bridge and closing the wavy wound gaps faster than straight gaps,” explained lead author Xu Hongmei, a doctoral student at NTU’s School of Mechanical and Aerospace Engineering, who seems to have time to toss out a tumblr or two to keep the press informed.

As for the rest of you, would it kill you to pick up a phone once in a while? Maybe let a journalist know that you’re still alive? We have feelings too, you know, and we worry.
 

A little Jekyll, a little Hyde, and a little shop of horrors

More “Little Shop of Horrors” references are coming, so be prepared.

We begin with Triphyophyllum peltatum. This woody vine is of great interest to medical and pharmaceutical researchers because its constituents have shown promise against pancreatic cancer and leukemia cells, among others, along with the pathogens that cause malaria and other diseases. There is another side, however. T. peltatum also has a tendency to turn into a realistic Audrey II when deprived.

No, of course they’re not craving human flesh, but it does become … carnivorous in its appetite.

T. peltatum, native to the West African tropics and not found in a New York florist shop, has the unique ability to change its diet and development based on the environmental circumstances. For some unknown reason, the leaves would develop adhesive traps in the form of sticky drops that capture insect prey. The plant is notoriously hard to grow, however, so no one could study the transformation under lab conditions. Until now.

Traud Winkelmann/University of Hannover

A group of German scientists “exposed the plant to different stress factors, including deficiencies of various nutrients, and studied how it responded to each,” said Dr. Traud Winkelmann of Leibniz University Hannover. “Only in one case were we able to observe the formation of traps: in the case of a lack of phosphorus.”

Well, there you have it: phosphorus. We need it for healthy bones and teeth, which this plant doesn’t have to worry about, unlike its Tony Award–nominated counterpart. The investigators hope that their findings could lead to “future molecular analyses that will help understand the origins of carnivory,” but we’re guessing that a certain singing alien species will be left out of that research.

Fastest peptide north, south, east, aaaaand west of the Pecos

Bacterial infections are supposed to be simple. You get infected, you get an antibiotic to treat it. Easy. Some bacteria, though, don’t play by the rules. Those antibiotics may kill 99.9% of germs, but what about the 0.1% that gets left behind? With their fallen comrades out of the way, the accidentally drug resistant species are free to inherit the Earth.

Antibiotic resistance is thus a major concern for the medical community. Naturally, anything that prevents doctors from successfully curing sick people is a priority. Unless you’re a major pharmaceutical company that has been loath to develop new drugs that can beat antibiotic-resistant bacteria. Blah blah, time and money, blah blah, long time between development and market application, blah blah, no profit. We all know the story with pharmaceutical companies.

Ilana Camargo

Research from other sources has continued, however, and Brazilian scientists recently published research involving a peptide known as plantaricin 149. This peptide, derived from the bacterium Lactobacillus plantarum, has been known for nearly 30 years to have antibacterial properties. Pln149 in its natural state, though, is not particularly efficient at bacteria-killing. Fortunately, we have science and technology on our side.

The researchers synthesized 20 analogs of Pln149, of which Pln149-PEP20 had the best results. The elegantly named compound is less than half the size of the original peptide, less toxic, and far better at killing any and all drug-resistant bacteria the researchers threw at it. How much better? Pln149-PEP20 started killing bacteria less than an hour after being introduced in lab trials.

The research is just in its early days – just because something is less toxic doesn’t necessarily mean you want to go and help yourself to it – but we can only hope that those lovely pharmaceutical companies deign to look down upon us and actually develop a drug utilizing Pln149-PEP20 to, you know, actually help sick people, instead of trying to build monopolies or avoiding paying billions in taxes. Yeah, we couldn’t keep a straight face through that last sentence either.
 

Speed healing: The wavy wound gets the swirl

Did you know that wavy wounds heal faster than straight wounds? Well, we didn’t, but apparently quite a few people did, because somebody has been trying to figure out why wavy wounds heal faster than straight ones. Do the surgeons know about this? How about you dermatologists? Wavy over straight? We’re the media. We’re supposed to report this kind of stuff. Maybe hit us with a tweet next time you do something important, or push a TikTok our way, okay?

You could be more like the investigators at Nanyang Technological University in Singapore, who figured out the why and then released a statement about it.

NTU Singapore

They created synthetic wounds – some straight, some wavy – in micropatterned hydrogel substrates that mimicked human skin. Then they used an advanced optical technique known as particle image velocimetry to measure fluid flow and learn how cells moved to close the wound gaps.

The wavy wounds “induced more complex collective cell movements, such as a swirly, vortex-like motion,” according to the written statement from NTU Singapore. In the straight wounds, cell movements paralleled the wound front, “moving in straight lines like a marching band,” they pointed out, unlike some researchers who never call us unless they need money.

Complex epithelial cell movements are better, it turns out. Over an observation period of 64 hours the NTU team found that the healing efficiency of wavy gaps – measured by the area covered by the cells over time – is nearly five times faster than straight gaps.

The complex motion “enabled cells to quickly connect with similar cells on the opposite site of the wound edge, forming a bridge and closing the wavy wound gaps faster than straight gaps,” explained lead author Xu Hongmei, a doctoral student at NTU’s School of Mechanical and Aerospace Engineering, who seems to have time to toss out a tumblr or two to keep the press informed.

As for the rest of you, would it kill you to pick up a phone once in a while? Maybe let a journalist know that you’re still alive? We have feelings too, you know, and we worry.
 

A little Jekyll, a little Hyde, and a little shop of horrors

More “Little Shop of Horrors” references are coming, so be prepared.

We begin with Triphyophyllum peltatum. This woody vine is of great interest to medical and pharmaceutical researchers because its constituents have shown promise against pancreatic cancer and leukemia cells, among others, along with the pathogens that cause malaria and other diseases. There is another side, however. T. peltatum also has a tendency to turn into a realistic Audrey II when deprived.

No, of course they’re not craving human flesh, but it does become … carnivorous in its appetite.

T. peltatum, native to the West African tropics and not found in a New York florist shop, has the unique ability to change its diet and development based on the environmental circumstances. For some unknown reason, the leaves would develop adhesive traps in the form of sticky drops that capture insect prey. The plant is notoriously hard to grow, however, so no one could study the transformation under lab conditions. Until now.

Traud Winkelmann/University of Hannover

A group of German scientists “exposed the plant to different stress factors, including deficiencies of various nutrients, and studied how it responded to each,” said Dr. Traud Winkelmann of Leibniz University Hannover. “Only in one case were we able to observe the formation of traps: in the case of a lack of phosphorus.”

Well, there you have it: phosphorus. We need it for healthy bones and teeth, which this plant doesn’t have to worry about, unlike its Tony Award–nominated counterpart. The investigators hope that their findings could lead to “future molecular analyses that will help understand the origins of carnivory,” but we’re guessing that a certain singing alien species will be left out of that research.

The Federal Trade Commission’s proposed regulation that would ban noncompete agreements across the country seems like potential good news for doctors. Of course, many hospitals and employers are against it. As a result, the FTC’s sweeping proposal has tongues wagging on both sides of the issue.

Many physicians are thrilled that they may soon have more control over their career and not be stuck in jobs where they feel frustrated, underpaid, or blocked in their progress.

If passed, the proposed ban would allow physicians to get a new job with a competing organization, bucking a long-standing trend that hospitals and health care systems have heavily relied on to keep staff in place. As of 2018, as many as 45% of primary care physicians had inked such agreements with their employers.

Typically, the agreements prevent physicians from practicing medicine with a new employer for a defined period within a specific geographic area. No matter how attractive an alternate offer of employment might be, doctors are bound by the agreements to say no if the offer exists in that defined area and time period.

The period for public comment on the proposed regulation ended on April 19, and there is currently no set date for a decision.

In a Medscape poll of 558 physicians, more than 9 out of 10 respondents said that they were either currently bound by a noncompete clause or that they had been bound by one in the past that had forced them to temporarily stop working, commute long distances, move to a different area, or switch fields.

The new proposal would make it illegal for an employer, such as a hospital or large group, to enter a noncompete with a worker; maintain a noncompete with a worker; or represent to a worker, under certain circumstances, that the worker is subject to a noncompete.

It also would not only ban future noncompete agreements but also retroactively invalidate existing ones. The FTC reasons that noncompete clauses could potentially increase worker earnings as well as lower health care costs by billions of dollars. If the ruling were to move forward, it would represent part of President Biden’s “worker-forward” priorities, focusing on how competition can be a good thing for employees. The President billed the FTC’s announcement as a “huge win for workers.”

In its statements on the proposed ban, the FTC claimed that it could lower consumer prices across the board by as much as $150 billion per year and return nearly $300 million to workers each year.

However, even if passed, the draft rule would keep in place nonsolicitation rules that many health care organizations have put into place. That means that, if a physician leaves an employer, he or she cannot reach out to former patients and colleagues to bring them along or invite them to switch to him or her in the new job.

Within that clause, however, the FTC has specified that if such nonsolicitation agreement has the “equivalent effect” of a noncompete, the agency would deem it such. That means, even if that rule stays, it could be contested and may be interpreted as violating the noncompete law. So there’s value in reading all the fine print should the ban move forward.
 

Could the ban bring potential downsides?

Most physicians view the potential to break free of a noncompete agreement as a victory. Peter Glennon, an employment litigation attorney with The Glennon Law Firm in Rochester, N.Y., says not so fast. “If you ask anyone if they’d prefer a noncompete agreement, of course they’re going to say no,” he said in an interview. “It sounds like a restriction, one that can hold you back.”

Mr. Glennon believes that there are actually upsides to physician noncompetes. For instance, many noncompetes come with sign-on bonuses that could potentially disappear without the agreements. There’s also the fact that when some physicians sign a noncompete agreement, they then receive pro bono training and continuing education along with marketing and promotion of their skills. Without signing a noncompete, employers may be less incentivized to provide all those benefits to their physician employers.

Those benefits – and the noncompetes – also vary by specialty, Mr. Glennon said. “In 2021, Washington, DC, banned noncompetes for doctors making less than $250,000. So, most generalists there can walk across the street and get a new job. For specialists like cardiologists or neurosurgeons, however, advanced training and marketing benefits matter, so many of them don’t want to lose noncompetes.”

Still, most physicians hope that the FTC’s ban takes hold. Manan Shah, MD, founder, and chief medical officer at Wyndly, an allergy relief startup practice, is one of them.

“Initially, it might disincentivize hospital systems from helping new physicians build up their name and practice because they might be concerned about a physician leaving and starting anew,” he said. “But in the long term, hospitals require physicians to bring their patients to them for care, so the best hospitals will always compete for the best physicians and support them as they build up their practice.”

Dr. Shah views noncompetes as overly prohibitive to physicians. “Right now, if a physician starts a job at a large hospital system and realizes they want to switch jobs, the noncompete distances are so wide they often have to move cities to continue practicing,” he said. “Picking up and starting over in a new city isn’t an option for everyone and can be especially difficult for someone with a family.”

Where Mr. Glennon argued that a physician leaving a team-based practice might harm patients, Shah takes a different perspective. “Imagine you have a doctor whom you trust and have been working with,” he said. “If something changes at their hospital and they decide to move, you literally have to find a new doctor instead of just being able to see them at another location down the street.”

Another potential burden of the noncompete agreements is that they could possibly squelch doctor’s desires to hang up their own shingle. According to Dr. Shah, the agreements make it so that if a physician wants to work independently, it’s nearly impossible to fly solo. “This is frustrating because independent practices have been shown to be more cost effective and allow patients to build better relationships with their doctors,” he claimed.

A 2016 study from Annals of Family Medicine supports that claim, at least for small general practices. Another study appearing in JAMA concurred. It does point out, however, that the cost equation is nuanced and that benefits of larger systems include more resilience to economic downturns and can provide more specialized care.
 

Will nonprofit hospitals be subject to this noncompete ban?

Further complicating the noncompete ban issue is how it might impact nonprofit institutions versus their for-profit peers. Most hospitals structured as nonprofits would be exempt from the rule because the FTC Act provides that it can enforce against “persons, partnerships, or corporations,” which are further defined as entities “organized to carry on business for their own profit or that of their members.”

The fallout from this, said Dr. Shah, is that it “would disproportionately affect health care providers, since many hospital systems are nonprofits. This is disconcerting because we know that many nonprofit systems make large profits anyway and can offer executive teams’ lucrative packages, while the nurses, assistants, and physicians providing the care are generally not well compensated.”

So far, about nine states plus Washington, D.C., have already put noncompete bans in place, and they may serve as a harbinger of things to come should the federal ban go into effect. Each varies in its specifics. Some, like Indiana, outright ban them, whereas others limit them based on variables like income and industry. “We’re seeing these states responding to local market conditions,” said Darryl Drevna, senior director of regulatory affairs at the American Medical Group Association. “Health care is a hyperlocal market. Depending on the situation, the bans adapt and respond specific to those states.”

Should the federal ban take hold, however, it will supersede whatever rules the individual states have in place.

Some opponents of the federal ban proposal question its authority to begin with, however, Mr. Glennon included. “Many people believe the FTC is overstepping,” he said. “Some people believe that Section 5 of the FTC Act does not give it the authority to police labor markets.”

Mr. Drevna noted that the FTC has taken an aggressive stance, one that will ultimately wind up in the courts. “How it works out is anyone’s guess,” he said. “Ideally, the FTC will consider the comments and concerns of groups like AMGA and realize that states are best suited to regulate in this area.”

In general, the ban’s supporters are employees/physicians; those who oppose it are their employers. Joining the AMGA in speaking out against the noncompete ban is the American Hospital Association, whereas the American College of Emergency Physicians has come out largely in support of the ban.

Still, doctors like Dr. Shah remain hopeful. “I am optimistic that perhaps my colleagues will not continue to be stuck in overrestrictive noncompetes, but I am also realistic,” he said. “Hospital systems are already coming out strongly against this and they have deep pockets, so I won’t be surprised if it does not come to pass.”

A version of this article first appeared on Medscape.com.

The Federal Trade Commission’s proposed regulation that would ban noncompete agreements across the country seems like potential good news for doctors. Of course, many hospitals and employers are against it. As a result, the FTC’s sweeping proposal has tongues wagging on both sides of the issue.

Many physicians are thrilled that they may soon have more control over their career and not be stuck in jobs where they feel frustrated, underpaid, or blocked in their progress.

If passed, the proposed ban would allow physicians to get a new job with a competing organization, bucking a long-standing trend that hospitals and health care systems have heavily relied on to keep staff in place. As of 2018, as many as 45% of primary care physicians had inked such agreements with their employers.

Typically, the agreements prevent physicians from practicing medicine with a new employer for a defined period within a specific geographic area. No matter how attractive an alternate offer of employment might be, doctors are bound by the agreements to say no if the offer exists in that defined area and time period.

The period for public comment on the proposed regulation ended on April 19, and there is currently no set date for a decision.

In a Medscape poll of 558 physicians, more than 9 out of 10 respondents said that they were either currently bound by a noncompete clause or that they had been bound by one in the past that had forced them to temporarily stop working, commute long distances, move to a different area, or switch fields.

The new proposal would make it illegal for an employer, such as a hospital or large group, to enter a noncompete with a worker; maintain a noncompete with a worker; or represent to a worker, under certain circumstances, that the worker is subject to a noncompete.

It also would not only ban future noncompete agreements but also retroactively invalidate existing ones. The FTC reasons that noncompete clauses could potentially increase worker earnings as well as lower health care costs by billions of dollars. If the ruling were to move forward, it would represent part of President Biden’s “worker-forward” priorities, focusing on how competition can be a good thing for employees. The President billed the FTC’s announcement as a “huge win for workers.”

In its statements on the proposed ban, the FTC claimed that it could lower consumer prices across the board by as much as $150 billion per year and return nearly $300 million to workers each year.

However, even if passed, the draft rule would keep in place nonsolicitation rules that many health care organizations have put into place. That means that, if a physician leaves an employer, he or she cannot reach out to former patients and colleagues to bring them along or invite them to switch to him or her in the new job.

Within that clause, however, the FTC has specified that if such nonsolicitation agreement has the “equivalent effect” of a noncompete, the agency would deem it such. That means, even if that rule stays, it could be contested and may be interpreted as violating the noncompete law. So there’s value in reading all the fine print should the ban move forward.
 

Could the ban bring potential downsides?

Most physicians view the potential to break free of a noncompete agreement as a victory. Peter Glennon, an employment litigation attorney with The Glennon Law Firm in Rochester, N.Y., says not so fast. “If you ask anyone if they’d prefer a noncompete agreement, of course they’re going to say no,” he said in an interview. “It sounds like a restriction, one that can hold you back.”

Mr. Glennon believes that there are actually upsides to physician noncompetes. For instance, many noncompetes come with sign-on bonuses that could potentially disappear without the agreements. There’s also the fact that when some physicians sign a noncompete agreement, they then receive pro bono training and continuing education along with marketing and promotion of their skills. Without signing a noncompete, employers may be less incentivized to provide all those benefits to their physician employers.

Those benefits – and the noncompetes – also vary by specialty, Mr. Glennon said. “In 2021, Washington, DC, banned noncompetes for doctors making less than $250,000. So, most generalists there can walk across the street and get a new job. For specialists like cardiologists or neurosurgeons, however, advanced training and marketing benefits matter, so many of them don’t want to lose noncompetes.”

Still, most physicians hope that the FTC’s ban takes hold. Manan Shah, MD, founder, and chief medical officer at Wyndly, an allergy relief startup practice, is one of them.

“Initially, it might disincentivize hospital systems from helping new physicians build up their name and practice because they might be concerned about a physician leaving and starting anew,” he said. “But in the long term, hospitals require physicians to bring their patients to them for care, so the best hospitals will always compete for the best physicians and support them as they build up their practice.”

Dr. Shah views noncompetes as overly prohibitive to physicians. “Right now, if a physician starts a job at a large hospital system and realizes they want to switch jobs, the noncompete distances are so wide they often have to move cities to continue practicing,” he said. “Picking up and starting over in a new city isn’t an option for everyone and can be especially difficult for someone with a family.”

Where Mr. Glennon argued that a physician leaving a team-based practice might harm patients, Shah takes a different perspective. “Imagine you have a doctor whom you trust and have been working with,” he said. “If something changes at their hospital and they decide to move, you literally have to find a new doctor instead of just being able to see them at another location down the street.”

Another potential burden of the noncompete agreements is that they could possibly squelch doctor’s desires to hang up their own shingle. According to Dr. Shah, the agreements make it so that if a physician wants to work independently, it’s nearly impossible to fly solo. “This is frustrating because independent practices have been shown to be more cost effective and allow patients to build better relationships with their doctors,” he claimed.

A 2016 study from Annals of Family Medicine supports that claim, at least for small general practices. Another study appearing in JAMA concurred. It does point out, however, that the cost equation is nuanced and that benefits of larger systems include more resilience to economic downturns and can provide more specialized care.
 

Will nonprofit hospitals be subject to this noncompete ban?

Further complicating the noncompete ban issue is how it might impact nonprofit institutions versus their for-profit peers. Most hospitals structured as nonprofits would be exempt from the rule because the FTC Act provides that it can enforce against “persons, partnerships, or corporations,” which are further defined as entities “organized to carry on business for their own profit or that of their members.”

The fallout from this, said Dr. Shah, is that it “would disproportionately affect health care providers, since many hospital systems are nonprofits. This is disconcerting because we know that many nonprofit systems make large profits anyway and can offer executive teams’ lucrative packages, while the nurses, assistants, and physicians providing the care are generally not well compensated.”

So far, about nine states plus Washington, D.C., have already put noncompete bans in place, and they may serve as a harbinger of things to come should the federal ban go into effect. Each varies in its specifics. Some, like Indiana, outright ban them, whereas others limit them based on variables like income and industry. “We’re seeing these states responding to local market conditions,” said Darryl Drevna, senior director of regulatory affairs at the American Medical Group Association. “Health care is a hyperlocal market. Depending on the situation, the bans adapt and respond specific to those states.”

Should the federal ban take hold, however, it will supersede whatever rules the individual states have in place.

Some opponents of the federal ban proposal question its authority to begin with, however, Mr. Glennon included. “Many people believe the FTC is overstepping,” he said. “Some people believe that Section 5 of the FTC Act does not give it the authority to police labor markets.”

Mr. Drevna noted that the FTC has taken an aggressive stance, one that will ultimately wind up in the courts. “How it works out is anyone’s guess,” he said. “Ideally, the FTC will consider the comments and concerns of groups like AMGA and realize that states are best suited to regulate in this area.”

In general, the ban’s supporters are employees/physicians; those who oppose it are their employers. Joining the AMGA in speaking out against the noncompete ban is the American Hospital Association, whereas the American College of Emergency Physicians has come out largely in support of the ban.

Still, doctors like Dr. Shah remain hopeful. “I am optimistic that perhaps my colleagues will not continue to be stuck in overrestrictive noncompetes, but I am also realistic,” he said. “Hospital systems are already coming out strongly against this and they have deep pockets, so I won’t be surprised if it does not come to pass.”

A version of this article first appeared on Medscape.com.

The Federal Trade Commission’s proposed regulation that would ban noncompete agreements across the country seems like potential good news for doctors. Of course, many hospitals and employers are against it. As a result, the FTC’s sweeping proposal has tongues wagging on both sides of the issue.

Many physicians are thrilled that they may soon have more control over their career and not be stuck in jobs where they feel frustrated, underpaid, or blocked in their progress.

If passed, the proposed ban would allow physicians to get a new job with a competing organization, bucking a long-standing trend that hospitals and health care systems have heavily relied on to keep staff in place. As of 2018, as many as 45% of primary care physicians had inked such agreements with their employers.

Typically, the agreements prevent physicians from practicing medicine with a new employer for a defined period within a specific geographic area. No matter how attractive an alternate offer of employment might be, doctors are bound by the agreements to say no if the offer exists in that defined area and time period.

The period for public comment on the proposed regulation ended on April 19, and there is currently no set date for a decision.

In a Medscape poll of 558 physicians, more than 9 out of 10 respondents said that they were either currently bound by a noncompete clause or that they had been bound by one in the past that had forced them to temporarily stop working, commute long distances, move to a different area, or switch fields.

The new proposal would make it illegal for an employer, such as a hospital or large group, to enter a noncompete with a worker; maintain a noncompete with a worker; or represent to a worker, under certain circumstances, that the worker is subject to a noncompete.

It also would not only ban future noncompete agreements but also retroactively invalidate existing ones. The FTC reasons that noncompete clauses could potentially increase worker earnings as well as lower health care costs by billions of dollars. If the ruling were to move forward, it would represent part of President Biden’s “worker-forward” priorities, focusing on how competition can be a good thing for employees. The President billed the FTC’s announcement as a “huge win for workers.”

In its statements on the proposed ban, the FTC claimed that it could lower consumer prices across the board by as much as $150 billion per year and return nearly $300 million to workers each year.

However, even if passed, the draft rule would keep in place nonsolicitation rules that many health care organizations have put into place. That means that, if a physician leaves an employer, he or she cannot reach out to former patients and colleagues to bring them along or invite them to switch to him or her in the new job.

Within that clause, however, the FTC has specified that if such nonsolicitation agreement has the “equivalent effect” of a noncompete, the agency would deem it such. That means, even if that rule stays, it could be contested and may be interpreted as violating the noncompete law. So there’s value in reading all the fine print should the ban move forward.
 

Could the ban bring potential downsides?

Most physicians view the potential to break free of a noncompete agreement as a victory. Peter Glennon, an employment litigation attorney with The Glennon Law Firm in Rochester, N.Y., says not so fast. “If you ask anyone if they’d prefer a noncompete agreement, of course they’re going to say no,” he said in an interview. “It sounds like a restriction, one that can hold you back.”

Mr. Glennon believes that there are actually upsides to physician noncompetes. For instance, many noncompetes come with sign-on bonuses that could potentially disappear without the agreements. There’s also the fact that when some physicians sign a noncompete agreement, they then receive pro bono training and continuing education along with marketing and promotion of their skills. Without signing a noncompete, employers may be less incentivized to provide all those benefits to their physician employers.

Those benefits – and the noncompetes – also vary by specialty, Mr. Glennon said. “In 2021, Washington, DC, banned noncompetes for doctors making less than $250,000. So, most generalists there can walk across the street and get a new job. For specialists like cardiologists or neurosurgeons, however, advanced training and marketing benefits matter, so many of them don’t want to lose noncompetes.”

Still, most physicians hope that the FTC’s ban takes hold. Manan Shah, MD, founder, and chief medical officer at Wyndly, an allergy relief startup practice, is one of them.

“Initially, it might disincentivize hospital systems from helping new physicians build up their name and practice because they might be concerned about a physician leaving and starting anew,” he said. “But in the long term, hospitals require physicians to bring their patients to them for care, so the best hospitals will always compete for the best physicians and support them as they build up their practice.”

Dr. Shah views noncompetes as overly prohibitive to physicians. “Right now, if a physician starts a job at a large hospital system and realizes they want to switch jobs, the noncompete distances are so wide they often have to move cities to continue practicing,” he said. “Picking up and starting over in a new city isn’t an option for everyone and can be especially difficult for someone with a family.”

Where Mr. Glennon argued that a physician leaving a team-based practice might harm patients, Shah takes a different perspective. “Imagine you have a doctor whom you trust and have been working with,” he said. “If something changes at their hospital and they decide to move, you literally have to find a new doctor instead of just being able to see them at another location down the street.”

Another potential burden of the noncompete agreements is that they could possibly squelch doctor’s desires to hang up their own shingle. According to Dr. Shah, the agreements make it so that if a physician wants to work independently, it’s nearly impossible to fly solo. “This is frustrating because independent practices have been shown to be more cost effective and allow patients to build better relationships with their doctors,” he claimed.

A 2016 study from Annals of Family Medicine supports that claim, at least for small general practices. Another study appearing in JAMA concurred. It does point out, however, that the cost equation is nuanced and that benefits of larger systems include more resilience to economic downturns and can provide more specialized care.
 

Will nonprofit hospitals be subject to this noncompete ban?

Further complicating the noncompete ban issue is how it might impact nonprofit institutions versus their for-profit peers. Most hospitals structured as nonprofits would be exempt from the rule because the FTC Act provides that it can enforce against “persons, partnerships, or corporations,” which are further defined as entities “organized to carry on business for their own profit or that of their members.”

The fallout from this, said Dr. Shah, is that it “would disproportionately affect health care providers, since many hospital systems are nonprofits. This is disconcerting because we know that many nonprofit systems make large profits anyway and can offer executive teams’ lucrative packages, while the nurses, assistants, and physicians providing the care are generally not well compensated.”

So far, about nine states plus Washington, D.C., have already put noncompete bans in place, and they may serve as a harbinger of things to come should the federal ban go into effect. Each varies in its specifics. Some, like Indiana, outright ban them, whereas others limit them based on variables like income and industry. “We’re seeing these states responding to local market conditions,” said Darryl Drevna, senior director of regulatory affairs at the American Medical Group Association. “Health care is a hyperlocal market. Depending on the situation, the bans adapt and respond specific to those states.”

Should the federal ban take hold, however, it will supersede whatever rules the individual states have in place.

Some opponents of the federal ban proposal question its authority to begin with, however, Mr. Glennon included. “Many people believe the FTC is overstepping,” he said. “Some people believe that Section 5 of the FTC Act does not give it the authority to police labor markets.”

Mr. Drevna noted that the FTC has taken an aggressive stance, one that will ultimately wind up in the courts. “How it works out is anyone’s guess,” he said. “Ideally, the FTC will consider the comments and concerns of groups like AMGA and realize that states are best suited to regulate in this area.”

In general, the ban’s supporters are employees/physicians; those who oppose it are their employers. Joining the AMGA in speaking out against the noncompete ban is the American Hospital Association, whereas the American College of Emergency Physicians has come out largely in support of the ban.

Still, doctors like Dr. Shah remain hopeful. “I am optimistic that perhaps my colleagues will not continue to be stuck in overrestrictive noncompetes, but I am also realistic,” he said. “Hospital systems are already coming out strongly against this and they have deep pockets, so I won’t be surprised if it does not come to pass.”

A version of this article first appeared on Medscape.com.

Hagop Kantarjian, MD, has been named the recipient of the 2023 David A. Karnofsky Memorial Award by the American Society of Clinical Oncology in recognition of his practice-changing clinical-translational research in leukemia.

This award is the society’s “highest scientific honor, and I am extremely happy and honored to receive it,” Dr. Kantarjian commented in an interview with this news organization.

Dr. Kantarjian serves as the chair of the department of leukemia and currently holds the Samsung Distinguished University Chair in Cancer Medicine at the University of Texas MD Anderson Cancer Center, Houston.

“No doubt that this is not an individual award. It represents an award for the accomplishments of all the leukemia faculty at MD Anderson across 4 decades. It’s really a teamwork effort that led to so many discoveries and improvements in treatment and care of patients with leukemia,” he commented.

The David A. Karnofsky Memorial Award has been presented annually since 1970 to recognize oncologists who have made outstanding contributions to cancer research, diagnosis, or treatment, ASCO noted.
 

From Lebanon to Texas

Dr. Kantarjian received his medical degree from the American University of Beirut, in Lebanon, in 1979 and completed his residency in internal medicine at the same institution in 1981.

It was his experience at MD Anderson as a young medical student and later as a fellow that fueled his interest and career in leukemia, he said.

“In 1978, I took a 4-month elective at MD Anderson, and I soon realized how different and innovative the atmosphere at MD Anderson was, compared to where I was training in Lebanon,” Dr. Kantarjian told this news organization.

Working with mentors that included MD Anderson heavyweights Emil Freireich, MD, Kenneth McCredie, MD, and Michael Keating, MD, helped shape his career and guide his leukemia research, he said.
 

Transformative impact on leukemia outcomes

The award citation notes that over the past 4 decades, Dr. Kantarjian’s research has transformed some standards of care and has dramatically improved survival in several leukemia subtypes, including chronic myeloid leukemia (CML), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and acute lymphocytic leukemia (ALL).

“Four decades ago, most of the leukemias were incurable. Today, most of the leukemias are potentially curable with targeted therapies. That’s what I am most proud of,” Dr. Kantarjian told this news organization.

Among Dr. Kantarjian’s contributions to the field of leukemia:

• Developing the HYPER-CVAD regimen (hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone) as a standard-of-care, frontline therapy for adults with ALL.
• Establishing clinical biology parameters of CML, including definitions of CML phases and cytogenetic responses, and establishing new prognostic factors that were subsequently adopted in studies of tyrosine kinase inhibitors.
• Leading the development of decitabine and epigenetic hypomethylation therapy for MDS and for older/unfit patients with AML.
• Pioneering research with hypomethylating agents (HMAs) in combination with venetoclax, which led to FDA approval of HMA-venetoclax combinations for older/unfit patients with AML.
• Championing the development of clofarabine, conducting animal toxicology studies, and leading subsequent phase 1 and 2 trials and pivotal phase 3 and 4 trials that led to FDA approval of clofarabine for pediatric ALL.
• Developing several FLT3 inhibitors, isocitrate dehydrogenase inhibitors, and venetoclax, which all received FDA approval for the treatment of AML and its subsets.
• Developing regimens for inotuzumab and blinatumomab combined with chemotherapy for adults with pre-B ALL.
• Working on the development of imatinib, dasatinib, nilotinib, bosutinib, ponatinib, and omacetaxine, which all received FDA approval for CML therapy.

“Dr. Kantarjian’s long list of accomplishments and groundbreaking discoveries are a testament to his lifelong commitment to impactful cancer research and patient care,” Giulio Draetta, MD, PhD, chief scientific officer at MD Anderson, said in a statement.
 

Giving back

Dr. Kantarjian has written more than 2,200 peer-reviewed articles and more than 100 book chapters. In 2012, he cofounded the Society of Hematologic Oncology, which has now expanded worldwide.

He has served on multiple ASCO committees throughout the years and served on the ASCO board of directors from 2010 to 2015.

Dr. Kantarjian is passionately involved in mentoring and education. In 2000 he created the MD Anderson Leukemia Fellowship, which now trains about 10 fellows in leukemia annually.

He is a nonresident fellow in health care at the Rice Baker Institute and has written extensively on important health care issues in cancer, including the importance of universal equitable health care, health care safety nets, health care as a human right, and the problem of drug shortages.

Dr. Kantarjian is a strong advocate for more affordable drug therapies. For years he has been outspoken about the high price of leukemia drugs and has written high-profile articles in medical journals. He has even appeared on a popular television program to publicize the issue.

“Drug costs have been increasing over time. If you think about it, even if you discover a drug that cures cancer, but the drug is affordable for the 1% of the patients, then you have no cure for cancer,” Dr. Kantarjian told this news organization.

“I started speaking about the issue of the cancer drug costs in 2012. Unfortunately, we have not made progress simply because of the for-profit nature of health care and the strong lobbying by drug companies,” he added. Dr. Kantarjian hopes new legislation will eventually turn the tide.

Dr. Kantarjian has received many other honors throughout his distinguished career, including the American Lebanese Medical Association’s Lifetime Achievement Award, the American Association for Cancer Research’s Joseph H. Burchenal Memorial Award, and the Leukemia Society of America’s Outstanding Service to Mankind Award. He also was named an ASCO Fellow and a Leukemia Society of America Special Fellow and Scholar.

Dr. Kantarjian will be presented with the 2023 David A. Karnofsky Memorial Award, which includes a $25,000 honorarium, and will give a scientific lecture about his research at the ASCO annual meeting in Chicago in early June.

A version of this article originally appeared on Medscape.com.

Hagop Kantarjian, MD, has been named the recipient of the 2023 David A. Karnofsky Memorial Award by the American Society of Clinical Oncology in recognition of his practice-changing clinical-translational research in leukemia.

This award is the society’s “highest scientific honor, and I am extremely happy and honored to receive it,” Dr. Kantarjian commented in an interview with this news organization.

Dr. Kantarjian serves as the chair of the department of leukemia and currently holds the Samsung Distinguished University Chair in Cancer Medicine at the University of Texas MD Anderson Cancer Center, Houston.

“No doubt that this is not an individual award. It represents an award for the accomplishments of all the leukemia faculty at MD Anderson across 4 decades. It’s really a teamwork effort that led to so many discoveries and improvements in treatment and care of patients with leukemia,” he commented.

The David A. Karnofsky Memorial Award has been presented annually since 1970 to recognize oncologists who have made outstanding contributions to cancer research, diagnosis, or treatment, ASCO noted.
 

From Lebanon to Texas

Dr. Kantarjian received his medical degree from the American University of Beirut, in Lebanon, in 1979 and completed his residency in internal medicine at the same institution in 1981.

It was his experience at MD Anderson as a young medical student and later as a fellow that fueled his interest and career in leukemia, he said.

“In 1978, I took a 4-month elective at MD Anderson, and I soon realized how different and innovative the atmosphere at MD Anderson was, compared to where I was training in Lebanon,” Dr. Kantarjian told this news organization.

Working with mentors that included MD Anderson heavyweights Emil Freireich, MD, Kenneth McCredie, MD, and Michael Keating, MD, helped shape his career and guide his leukemia research, he said.
 

Transformative impact on leukemia outcomes

The award citation notes that over the past 4 decades, Dr. Kantarjian’s research has transformed some standards of care and has dramatically improved survival in several leukemia subtypes, including chronic myeloid leukemia (CML), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and acute lymphocytic leukemia (ALL).

“Four decades ago, most of the leukemias were incurable. Today, most of the leukemias are potentially curable with targeted therapies. That’s what I am most proud of,” Dr. Kantarjian told this news organization.

Among Dr. Kantarjian’s contributions to the field of leukemia:

• Developing the HYPER-CVAD regimen (hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone) as a standard-of-care, frontline therapy for adults with ALL.
• Establishing clinical biology parameters of CML, including definitions of CML phases and cytogenetic responses, and establishing new prognostic factors that were subsequently adopted in studies of tyrosine kinase inhibitors.
• Leading the development of decitabine and epigenetic hypomethylation therapy for MDS and for older/unfit patients with AML.
• Pioneering research with hypomethylating agents (HMAs) in combination with venetoclax, which led to FDA approval of HMA-venetoclax combinations for older/unfit patients with AML.
• Championing the development of clofarabine, conducting animal toxicology studies, and leading subsequent phase 1 and 2 trials and pivotal phase 3 and 4 trials that led to FDA approval of clofarabine for pediatric ALL.
• Developing several FLT3 inhibitors, isocitrate dehydrogenase inhibitors, and venetoclax, which all received FDA approval for the treatment of AML and its subsets.
• Developing regimens for inotuzumab and blinatumomab combined with chemotherapy for adults with pre-B ALL.
• Working on the development of imatinib, dasatinib, nilotinib, bosutinib, ponatinib, and omacetaxine, which all received FDA approval for CML therapy.

“Dr. Kantarjian’s long list of accomplishments and groundbreaking discoveries are a testament to his lifelong commitment to impactful cancer research and patient care,” Giulio Draetta, MD, PhD, chief scientific officer at MD Anderson, said in a statement.
 

Giving back

Dr. Kantarjian has written more than 2,200 peer-reviewed articles and more than 100 book chapters. In 2012, he cofounded the Society of Hematologic Oncology, which has now expanded worldwide.

He has served on multiple ASCO committees throughout the years and served on the ASCO board of directors from 2010 to 2015.

Dr. Kantarjian is passionately involved in mentoring and education. In 2000 he created the MD Anderson Leukemia Fellowship, which now trains about 10 fellows in leukemia annually.

He is a nonresident fellow in health care at the Rice Baker Institute and has written extensively on important health care issues in cancer, including the importance of universal equitable health care, health care safety nets, health care as a human right, and the problem of drug shortages.

Dr. Kantarjian is a strong advocate for more affordable drug therapies. For years he has been outspoken about the high price of leukemia drugs and has written high-profile articles in medical journals. He has even appeared on a popular television program to publicize the issue.

“Drug costs have been increasing over time. If you think about it, even if you discover a drug that cures cancer, but the drug is affordable for the 1% of the patients, then you have no cure for cancer,” Dr. Kantarjian told this news organization.

“I started speaking about the issue of the cancer drug costs in 2012. Unfortunately, we have not made progress simply because of the for-profit nature of health care and the strong lobbying by drug companies,” he added. Dr. Kantarjian hopes new legislation will eventually turn the tide.

Dr. Kantarjian has received many other honors throughout his distinguished career, including the American Lebanese Medical Association’s Lifetime Achievement Award, the American Association for Cancer Research’s Joseph H. Burchenal Memorial Award, and the Leukemia Society of America’s Outstanding Service to Mankind Award. He also was named an ASCO Fellow and a Leukemia Society of America Special Fellow and Scholar.

Dr. Kantarjian will be presented with the 2023 David A. Karnofsky Memorial Award, which includes a $25,000 honorarium, and will give a scientific lecture about his research at the ASCO annual meeting in Chicago in early June.

A version of this article originally appeared on Medscape.com.

Hagop Kantarjian, MD, has been named the recipient of the 2023 David A. Karnofsky Memorial Award by the American Society of Clinical Oncology in recognition of his practice-changing clinical-translational research in leukemia.

This award is the society’s “highest scientific honor, and I am extremely happy and honored to receive it,” Dr. Kantarjian commented in an interview with this news organization.

Dr. Kantarjian serves as the chair of the department of leukemia and currently holds the Samsung Distinguished University Chair in Cancer Medicine at the University of Texas MD Anderson Cancer Center, Houston.

“No doubt that this is not an individual award. It represents an award for the accomplishments of all the leukemia faculty at MD Anderson across 4 decades. It’s really a teamwork effort that led to so many discoveries and improvements in treatment and care of patients with leukemia,” he commented.

The David A. Karnofsky Memorial Award has been presented annually since 1970 to recognize oncologists who have made outstanding contributions to cancer research, diagnosis, or treatment, ASCO noted.
 

From Lebanon to Texas

Dr. Kantarjian received his medical degree from the American University of Beirut, in Lebanon, in 1979 and completed his residency in internal medicine at the same institution in 1981.

It was his experience at MD Anderson as a young medical student and later as a fellow that fueled his interest and career in leukemia, he said.

“In 1978, I took a 4-month elective at MD Anderson, and I soon realized how different and innovative the atmosphere at MD Anderson was, compared to where I was training in Lebanon,” Dr. Kantarjian told this news organization.

Working with mentors that included MD Anderson heavyweights Emil Freireich, MD, Kenneth McCredie, MD, and Michael Keating, MD, helped shape his career and guide his leukemia research, he said.
 

Transformative impact on leukemia outcomes

The award citation notes that over the past 4 decades, Dr. Kantarjian’s research has transformed some standards of care and has dramatically improved survival in several leukemia subtypes, including chronic myeloid leukemia (CML), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and acute lymphocytic leukemia (ALL).

“Four decades ago, most of the leukemias were incurable. Today, most of the leukemias are potentially curable with targeted therapies. That’s what I am most proud of,” Dr. Kantarjian told this news organization.

Among Dr. Kantarjian’s contributions to the field of leukemia:

• Developing the HYPER-CVAD regimen (hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone) as a standard-of-care, frontline therapy for adults with ALL.
• Establishing clinical biology parameters of CML, including definitions of CML phases and cytogenetic responses, and establishing new prognostic factors that were subsequently adopted in studies of tyrosine kinase inhibitors.
• Leading the development of decitabine and epigenetic hypomethylation therapy for MDS and for older/unfit patients with AML.
• Pioneering research with hypomethylating agents (HMAs) in combination with venetoclax, which led to FDA approval of HMA-venetoclax combinations for older/unfit patients with AML.
• Championing the development of clofarabine, conducting animal toxicology studies, and leading subsequent phase 1 and 2 trials and pivotal phase 3 and 4 trials that led to FDA approval of clofarabine for pediatric ALL.
• Developing several FLT3 inhibitors, isocitrate dehydrogenase inhibitors, and venetoclax, which all received FDA approval for the treatment of AML and its subsets.
• Developing regimens for inotuzumab and blinatumomab combined with chemotherapy for adults with pre-B ALL.
• Working on the development of imatinib, dasatinib, nilotinib, bosutinib, ponatinib, and omacetaxine, which all received FDA approval for CML therapy.

“Dr. Kantarjian’s long list of accomplishments and groundbreaking discoveries are a testament to his lifelong commitment to impactful cancer research and patient care,” Giulio Draetta, MD, PhD, chief scientific officer at MD Anderson, said in a statement.
 

Giving back

Dr. Kantarjian has written more than 2,200 peer-reviewed articles and more than 100 book chapters. In 2012, he cofounded the Society of Hematologic Oncology, which has now expanded worldwide.

He has served on multiple ASCO committees throughout the years and served on the ASCO board of directors from 2010 to 2015.

Dr. Kantarjian is passionately involved in mentoring and education. In 2000 he created the MD Anderson Leukemia Fellowship, which now trains about 10 fellows in leukemia annually.

He is a nonresident fellow in health care at the Rice Baker Institute and has written extensively on important health care issues in cancer, including the importance of universal equitable health care, health care safety nets, health care as a human right, and the problem of drug shortages.

Dr. Kantarjian is a strong advocate for more affordable drug therapies. For years he has been outspoken about the high price of leukemia drugs and has written high-profile articles in medical journals. He has even appeared on a popular television program to publicize the issue.

“Drug costs have been increasing over time. If you think about it, even if you discover a drug that cures cancer, but the drug is affordable for the 1% of the patients, then you have no cure for cancer,” Dr. Kantarjian told this news organization.

“I started speaking about the issue of the cancer drug costs in 2012. Unfortunately, we have not made progress simply because of the for-profit nature of health care and the strong lobbying by drug companies,” he added. Dr. Kantarjian hopes new legislation will eventually turn the tide.

Dr. Kantarjian has received many other honors throughout his distinguished career, including the American Lebanese Medical Association’s Lifetime Achievement Award, the American Association for Cancer Research’s Joseph H. Burchenal Memorial Award, and the Leukemia Society of America’s Outstanding Service to Mankind Award. He also was named an ASCO Fellow and a Leukemia Society of America Special Fellow and Scholar.

Dr. Kantarjian will be presented with the 2023 David A. Karnofsky Memorial Award, which includes a $25,000 honorarium, and will give a scientific lecture about his research at the ASCO annual meeting in Chicago in early June.

A version of this article originally appeared on Medscape.com.